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 .
DETAILED ACTION
Applicant's preliminary amendment filed on February 20, 2026 is acknowledged. Claims 6, 14, 15, 17, 18, 20-35, 39, and 40 have been canceled. Claims 1-5, 7-13, 16, 19, 36-38, and 41-44 are pending.
Election/Restrictions
Applicant’s election of Group I (claims 1-5, 7-13, 16, 19, 36, 43, and 44) in the reply filed on February 20, 2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 37, 38, 41, and 42 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Claims 1-5, 7-13, 16, 19, 36, 43, and 44 are examined on the merits herein.
Priority
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Information Disclosure Statement
The information disclosure statement (IDS) submitted on February 7, 2023, June 15, 2023, January 19, 2024, February 2, 2024, February 28, 2024, June 17, 2024, and February 23, 2026 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
The information disclosure statement filed June 15, 2023 fails to comply with 37 CFR 1.98(a)(2), which requires a legible copy of each cited foreign patent document; each non-patent literature publication or that portion which caused it to be listed; and all other information or that portion which caused it to be listed. A copy of cite no. 163 was not provided; therefore, this citation was lined through on the IDS.
The information disclosure statement filed January 19, 2024 fails to comply with 37 CFR 1.98(a)(3)(i) because it does not include a concise explanation of the relevance, as it is presently understood by the individual designated in 37 CFR 1.56(c) most knowledgeable about the content of the information, of each reference listed that is not in the English language. Cite Nos. 170 and 171 are in a foreign language and a translation was not provided; therefore, these references were lined through on the IDS.
The information disclosure statement filed June 17, 2024 fails to comply with 37 CFR 1.98(a)(1), which requires the following: (1) a list of all patents, publications, applications, or other information submitted for consideration by the Office; (2) U.S. patents and U.S. patent application publications listed in a section separately from citations of other documents; (3) the application number of the application in which the information disclosure statement is being submitted on each page of the list; (4) a column that provides a blank space next to each document to be considered, for the examiner’s initials; and (5) a heading that clearly indicates that the list is an information disclosure statement. A copy of the following reference was submitted; however, the reference was not listed on the IDS.
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The information disclosure statement filed February 23, 2026 fails to comply with 37 CFR 1.98(a)(1), which requires the following: (1) a list of all patents, publications, applications, or other information submitted for consideration by the Office; (2) U.S. patents and U.S. patent application publications listed in a section separately from citations of other documents; (3) the application number of the application in which the information disclosure statement is being submitted on each page of the list; (4) a column that provides a blank space next to each document to be considered, for the examiner’s initials; and (5) a heading that clearly indicates that the list is an information disclosure statement. A copy of the following reference (Final Office Action in Application No. 17/097,997, dated 09/29/2025, 60 pages) was submitted; however, the reference was not listed on the IDS.
The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Drawings
The drawings were received on November 9, 2022.
The drawings are objected to because Figures 4C, 7D, 8, 20A through 20D, 21A, 21B, 22A through 22C, 25D, and 27B are blurry.
In addition, the upper right figure on page 38 is labeled as “FIG. 29H” (reproduced below); however, the figure should be labeled as “FIG. 28H” (emphasis added).
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Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The disclosure is objected to because of the following informalities:
Page 4, line 26 reads in part “reverse-complimentary sequence” and should read “reverse-complementary sequence” (emphasis added).
Page 7, line 11 reads in part “Red indicates a positive ELISPOT response…”; however, color drawings were not submitted with the application.
Page 8, FIG. 14 does not provide a description for (B).
FIG. 18, FIG. 19A, and FIG. 19B refer to “red dots and bars”; however, color drawings were not submitted with the application.
A brief description is not explicitly provided for Figures 25A, 25B, and 25C in the brief description of the drawings section.
A brief description is not explicitly provided for Figures 31A and 31B in the brief description of the drawings section.
Appropriate correction is required.
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01. See e.g., pages 50 and 103.
Claim Objections
Claim 7 objected to because of the following informality:
Claim 7 is missing the word “at” in between “the” and “least”.
Appropriate correction is required.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 19 and 44 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Krol et al. (Cell 2010).
Regarding claims 19 and 44, the clause “for gene delivery which specifically represses expression of a gene product in dorsal root ganglia (DRG)” is the preamble and is interpreted as intended use of the invention while the body of the claim sets forth all the limitations.
Regarding claims 19 and 44, Krol et al. teaches an AAV-Rho-EGFP-triple sponge, harboring four sites for each of the miR-183/96/182 miRNAs as shown in Figure 2F (reproduced below). The sponge sequence was cloned into the 3’ UTR of an EGFP cDNA, whose expression is driven by the human rhodopsin (Rho) promoter, yielding AAV2-Rho-EGFP/triple [page 622, right column, first paragraph].
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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 1-5, 7, 9, 11, 13, 16, 36, and 43 are rejected under 35 U.S.C. 103 as being unpatentable over Krol et al. (Cell 2010) in view of Esteves et al. (WO 2018/226785).
Regarding claims 1, 4, 5, 11, 16, 36, and 43, Krol et al. teaches an AAV-Rho-EGFP-triple sponge, harboring four sites for each of the miR-183/96/182 miRNAs as shown in Figure 2F (reproduced below). The sponge sequence was cloned into the 3’ UTR of an EGFP cDNA, whose expression is driven by the human rhodopsin (Rho) promoter, yielding AAV2-Rho-EGFP/triple [page 622, right column, first paragraph].
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Regarding claims 2 and 3, Krol et al. teaches that sponge sequences specific for mouse miR-182, miR-183 and miR-96 were designed to have eight miRNA binding sites for each individual miRNA, interrupted by 15-nt spacers [page S4, Construction of Sponge Plasmids and Viruses].
Regarding claim 7, Krol et al. teaches that the at least eight miR target sequences are in a 3’ UTR as shown in Figure 2F that is 432 nucleotides in length. Krol et al. teaches that sponge sequences specific for mouse miR-182, miR-183 and miR-96 were designed to have eight miRNA binding sites for each individual miRNA, interrupted by 15-nt spacers [page S4, Construction of Sponge Plasmids and Viruses]. Figure S3F (reproduced below) shows for example that the miR-183 target sequence is about 21 nucleotides in length. Therefore, (12 spacers x 15 nt each = 180 nts) + (12 miR target sequences x 21 nt each = 252 nts) equals 432 nucleotides.
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Regarding claim 9, Krol et al. teaches that the miRNA sponge is placed about 15 nucleotides from the 3’ end of the gene coding sequence as shown in Figure S3c (reproduced below).
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Regarding claim 13, Krol et al. demonstrates in Figure 2F above that a spacer is located between each of the at least eight miR target sequences.
However, Krol et al. does not teach the gene product is a gene product to be delivered to a patient in need thereof. Krol et al. also does not teach that the vector genome further comprises at least one target sequence specific for miR-183 or miR-182 in a 5’ UTR (claim 11). Krol et al. also does not teach a pharmaceutical composition comprising the rAAV and a formulation buffer (claim 36).
Esteves et al. teaches that miRNA binding sites associated with gene expression negative feedback loops and miRNA binding sites that de-target transgene expression from non-target tissues enable tunable transgene expression within a narrow range compatible with normal protein function and avoidance of off-target transgene toxicity. Esteves et al. teaches compositions capable of treating diseases and disorders associated with loss of function mutations, for example Rett syndrome which is associated with loss of function mutations in the MECP2 gene [page 1, third paragraph]. Esteves et al. also teaches that compositions (e.g., recombinant nucleic acids, rAAVs, and pharmaceutical compositions) may be delivered to a subject according to any appropriate methods known in the art. In some embodiments, a subject is a human [page 26, last paragraph bridging to page 27]. In some embodiments, the compositions may comprise a rAAV [page 27, second full paragraph]. In some embodiments, a composition further comprises a pharmaceutically acceptable carrier such as saline which may be formulated with a variety of buffering solutions (e.g., phosphate buffered saline) [page 27, third full paragraph]. Esteves et al. also teaches that one or more binding sites for one or more of miRNAs are incorporated in a transgene of a rAAV vector. The target sites in the mRNA may be in the 5' UTR, the 3' UTR or in the coding region [page 22, first full paragraph]. In addition, Esteves et al. teaches that non-limiting examples of miRNA genes and their homologues useful in the compositions of the disclosure (e.g., for mediating self-regulated expression or de-targeting of a transgene) include hsa-miR-182 and hsa-miR-183 [page 13].
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the gene product in the vector of Krol et al. with the gene product of Esteves et al. because Krol et al. taught an AAV-Rho-EGFP-triple sponge, harboring four sites for each of the miR-183/96/182 miRNAs and Esteves et al. taught that one or more binding sites for one or more of miRNAs are incorporated in a transgene of a rAAV vector. Esteves et al. also taught that hsa-miR-182 and hsa-miR-183 are useful in the compositions of the disclosure and taught compositions capable of treating diseases and disorders associated with loss of function mutations in the MECP2 gene, for example Rett syndrome. One would have made such a modification because it would have amounted to a simple substitution of one known element for another to obtain predictable results.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the vector of Krol et al. wherein at least one target sequence specific for miR-183 or miR-182 is in a 5’ UTR because Krol et al. taught that the sponge sequence was cloned into the 3’ UTR of an EGFP cDNA and Esteves et al. taught that target sites in the mRNA may be in the 5' UTR or the 3' UTR. One would have made such a modification because it would have amounted to a simple substitution of one known element for another to obtain predictable results.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the rAAV of Krol et al. in a pharmaceutical composition comprising a formulation buffer as taught by Esteves et al. because Krol et al. taught an AAV-Rho-EGFP-triple sponge, harboring four sites for each of the miR-183/96/182 miRNAs and Esteves et al. taught delivery of compositions to a subject wherein the composition comprises a rAAV and a pharmaceutically acceptable carrier such as phosphate buffered saline. One of ordinary skill in the art would have made such a modification for the purposes of delivery of the rAAV to a subject.
Claims 8 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Krol et al. (Cell 2010) in view of Esteves et al. (WO 2018/226785) as applied to claims 1-5, 7, 9, 11, 13, 16, 36, and 43 above, and further in view of Vella et al. (Genes & Development 2004; reference cited by the Applicant).
Regarding claims 8 and 10, the teachings of Krol et al. and Esteves et al. are discussed above.
However, Krol et al. and Esteves et al. do not teach that the at least eight miR target sequences are continuous. Krol et al. and Esteves et al. do not teach that the 5’ end of the first of the at least eight miR target sequences is at least 100 nucleotides from the 3’ end of the gene coding sequence.
Vella et al. teaches let-7 complementary sites (LCSs) constructs with a col-10 promoter fused to the E. coli lacZ reporter gene. Each construct contains various LCSs from the C. elegans lin-41 3’ UTR inserted into the unc-54 3’UTR [page 133; Figure 1A]. Figure 1A (reproduced below) shows miRNA target sequences that are continuous (e.g., pMV1 - miR target sites 5, 3, and 1). Vella et al. also shows in Figure 1A that a miRNA sponge may comprise a miRNA target site placed at least 100 nucleotides from the 3’ end of the gene coding sequence (miR target site 4; designated by arrow).
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It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the vector of Krol et al. and Esteves et al. wherein the miR target sequences are continuous and wherein the 5’ end of the first of the at least eight miR target sequences is at least 100 nucleotides from the 3’ end of the gene coding sequence because Krol et al. taught that a spacer is located between each of the at least eight miR target sequences and Vella et al. taught that miRNA target sequences can be continuous or separated by a spacer. Vella et al. also taught that a miRNA sponge may comprise a miRNA target site placed at least 100 nucleotides from the 3’ end of the gene coding sequence. One would have made such a modification because it would have amounted to a simple substitution of one known element for another to obtain predictable results.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Krol et al. (Cell 2010) in view of Esteves et al. (WO 2018/226785) as applied to claims 1-5, 7, 9, 11, 13, 16, 36, and 43 above, and further in view of Li et al. (Breast Cancer Research 2014; reference cited by Applicant).
Regarding claim 12, the teachings of Krol et al. and Esteves et al. are discussed above.
However, Krol et al. and Esteves et al. do not teach wherein each of the at least eight target sequences comprises SEQ ID NO: 1.
Li et al. teaches a nucleic acid construct comprising a coding sequence of interest wherein the 3’ UTR of said coding sequence comprises a miRNA sponge comprising target sequences for miR-183, miR-96, and miR-182 [Figure 2, reproduced below].
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Li et al. shows in Figure S2B (above) the sponge element and the miR-183, miR-96, and miR-182 binding sequences. The figure also shows that the miR-183 target sequence is 100% complementary to miR-183 including the central bulge nucleotides. The miR-183 target sequence (top) has a match to instant SEQ ID NO: 1 (bottom) as shown below.
agtgaattct tggagtgcca ta (Li et al. miR-183 target sequence)
agtgaattct accagtgcca ta (SEQ ID NO: 1)
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the miR-183 target sequence in the vector of Krol et al. and Esteves et al. with the miR-183 target sequence of Li et al. because Krol et al. taught an AAV-Rho-EGFP-triple sponge, harboring four sites for each of the miR-183/96/182 miRNAs and Li et al. taught a nucleic acid construct comprising a miRNA sponge comprising the miR-183 target sequence. One would have made such a modification because it would have amounted to a simple substitution of one known element for another to obtain predictable results.
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.
Claims 1-5, 7-13, 16, 19, 36, 43, and 44 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 31-35, 41, and 43-57 of copending Application No. 17/097,997 in view of Krol et al. (Cell 2010).
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However, ‘997 does not teach wherein the vector genome comprises at least eight miR target sequences wherein each target sequence is specific for miR-183 or miR-182. Specifically, ‘997 does not teach that the at least eight miR target sequences comprise at least five target sequences specific for miR-183 or miR-182. In addition, ‘997 does not teach that the at least eight miR target sequences comprise four target sequences specific for miR-183 and four target sequences specific for miR-182. ‘997 does not teach that the vector genome comprises a tissue-specific, central nervous system-specific, or constitutive promoter.
Krol et al. teaches an AAV-Rho-EGFP-triple sponge, harboring four sites for each of the miR-183/96/182 miRNAs as shown in Figure 2F (reproduced below). The sponge sequence was cloned into the 3’ UTR of an EGFP cDNA, whose expression is driven by the human rhodopsin (Rho) promoter, yielding AAV2-Rho-EGFP/triple [page 622, right column, first paragraph].
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Krol et al. also teaches that sponge sequences specific for mouse miR-182, miR-183 and miR-96 were designed to have eight miRNA binding sites for each individual miRNA, interrupted by 15-nt spacers [page S4, Construction of Sponge Plasmids and Viruses].
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the rAAV of ‘997 with the teachings of Krol et al. because both ‘997 and Krol et al. taught a rAAV comprising a vector genome comprising nucleic acid coding sequence and miRNA target sequences for miR-183. Krol et al. also taught that the vector genome comprises a nucleic acid coding sequence and miRNA target sequence for miR-182. One of ordinary skill in the art would have had a reasonable expectation of success because Krol et al. successfully reduced to practice the design of a nucleic acid vector comprising a miRNA sponge comprising miR-182 and miR-183 binding sites.
This is a provisional nonstatutory double patenting rejection.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTINA TRAN whose telephone number is (571)270-0550. The examiner can normally be reached M-F 7:30 - 5:00pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jennifer Dunston can be reached at (571) 272-2916. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/C.T./
Examiner, Art Unit 1637
/Jennifer Dunston/Supervisory Patent Examiner, Art Unit 1637