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
Response to Amendment
Status of the Claims
Receipt of Applicant’s response, filed 21 Jan 2026 has been entered.
Claims 1, 5, 11, 13, 36, 38, 57, 60, 64, 66, 72, 74, 77, 81, 84, 87, 93, 131, 137, and 139 remain pending in the application.
Claims 1, 11, 13, 36, 57, 64, 72, and 139 are amended.
Claim 2-4, 6-10, 12, 14-35, 37, 39-56, 58, 59, 61-63, 65, 67-71, 73, 75, 76, 78-80, 82, 83, 85, 86, 88-92, 94-130, 132-136, 138, and 140-147 are canceled.
Claims 131 and 137 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Claims 1, 5, 11, 13, 36, 38, 57, 60, 64, 66, 72, 74, 77, 81, 84, 87, 93, and 139 are under consideration.
Objections Withdrawn
Objections to the Claims
The claim objections set forth in the Non-Final Office Action mailed 21 Oct 2025 are hereby withdrawn in light of applicant’s amendments of the claims.
Rejections Withdrawn
Rejections Pursuant to 35 USC § 112
The rejections pursuant to 35 U.S.C. 112(b) set forth in the Non-Final Office Action mailed 21 Oct 2025 are hereby partially withdrawn in light of applicants amendment of the claims. The rejections regarding referencing to compounds and tables in the claims is maintained below.
Rejections Pursuant to Double Patenting
The rejections under double patenting as being unpatentable over Application No. 17/279,460 and 17/279,508 are withdrawn in light of the abandonment of the copending applications.
Rejections Maintained
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 36, 38, 57, 60, 64, 66, 72, 74, 77, 81, 84, 87, 93 and 139 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 36, 38, 60, 66, 74, and 77 recite various compounds but do not indicate what these compounds are. It is thus unclear what compounds are intended to be represented by these numbers. Claims 57, 64, 72, 81, 84, 87, and 93 are included in this rejection as they depend directly, indirectly, or include all the limitations of independent claim 36.
Claims 36, 57, 64, 72, and 139 refer to compounds in various Tables found within the specification. It is noted that where possible, claims are to be complete in themselves and should not incorporate by reference to specific tables within the specification (see MPEP 2173.05(s)). Claims 38, 60, 66, 74, 77, 81, 84, 87, and 93 are included in this rejection as they depend directly, indirectly, or include all the limitations of independent claim 36.
Response to Arguments
Applicant's arguments filed 21 Jan 2026 have been fully considered but they are not persuasive. Applicant argues that MPEP 2173.05(s) allows for references to tables and they have chosen to reference the tables and compounds of the specification for conciseness (page 17 of remarks). The examiner is not persuaded by these remarks and notes that “where possible, claims are to be complete in themselves” and references to tables are permitted only when there is “no practical way to define the invention in words” and that referring to tables in the specification cannot be done merely as matter of convenience (MPEP 2173.05(s)). In this case it is possible to incorporate the subject matter into the claims and the applicant should amend the claims accordingly. Applicant further argues that MPEP 2173.01 allows for the applicant to be their own lexicographer and the compounds are defined in the specification and can thus be referenced in the claims. The examiner is not persuaded and notes that even though the applicant may be their own lexicographer and use terms in a manner contrary to or inconsistent with one or more of their ordinary meanings (MPEP 2173.05(a)), this does not negate the requirement that claims should be complete in themselves and the applicant should amend the claims to clearly recite the compounds.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or 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, 13, 36, 64, 84, 87, 93 and 139 are rejected under 35 U.S.C. 103 as being unpatentable over Zuckermann et al. (US 7,422,861, published 09 Sep 2008).
Zuckermann teaches a method for screening peptoids for transfecting a cell with an oligonucleotide (col 4 lines 8-10). Zuckerman teaches the peptoids for delivering oligonucleotides to cells (col 5 lines 46-51). Delivering and transfecting cells with oligonucleotides (i.e. polyanionic compounds) renders obvious a delivery vehicle composition as in claim 36 and the inclusion of polyanionic compounds as in claim 93 and the system for delivery of polyanionic compounds to target cells as in claim 1.
Zuckerman teaches peptoid structures as those of formula I (col 4 lines 30-64).
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Zuckerman renders obvious the lipidated cationic peptoid of claim 36 and claim 1. For example, as described above, Zuckerman teaches that the Ra group may be alkyl, R1 and R2 may be hydrogen, Rc may be NH2, m is from 2-50 and each Rb is individually selected from groups such as alkyl and aralkyl which may be substituted with groups such as amino groups. These groups are the same as the groups in the formulas presented in claim 36, for example, Formula (Ie) of claim 36 where R1 and R3 are alkyl groups, R5 is aminoalkyl, and R7 is NH2. The inclusion of the cationic component renders obvious claim 13 where the cationic component is at least 99 mol% and the shielding component is less than 1 mol% (condition b of claim 13) as the claim does not require the presence of a shielding component.
Zuckerman further teaches that the Ra component may be a lipid moiety to form a lipitoid compound (col 8 lines 21-54).
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In the formula taught above, L is a fatty acid derived group, the linker may be a direct bond, and R may be an alkyl or aralkyl group. The formula and these groups render obvious the anionic/zwitterionic lipidated peptoid of claims 1, 64 and 139, such as Formula (IIIb) where R1 is a lipid moiety, R11 is an aminoalkyl, Ra and Rb are hydrogen, R12 is C8-C24 alkyl or C1-C4 aralkyl and where R7 is -NH2. Zuckerman teaches the lipid component may be a phospholipid or a cholesterol group (col 8 line 11-39), rendering obvious the inclusion of a phospholipid and a sterol as in claims 5, 84 and 87.
Zuckerman does not expressly teach selecting the cationic and anionic/zwitterionic compounds with sufficient specificity to rise to the level of anticipation.
However, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to have delivered oligonucleotides (polyanionic compounds) with cationic and anionic/zwitterionic compounds as those of the formulas described above. One of ordinary skill in the art would have been motivated to do so as peptoid compounds are known for delivery and transfection of cells with oliogonucleotodies, as taught by Zuckerman. The compound formulas taught by Zuckerman render obvious the instant claims, as described above. One of ordinary skill in the art would have a reasonable expectation of forming a delivery vehicle composition with the compounds taught by Zuckerman since the modification of the prior art represents nothing more than the predictable use of prior art elements according to their established functions. The addition of both the cationic and the anionic/zwitterionic component in the delivery composition as in claim 64 is obvious as "It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980).
Accordingly, the instant claims are rendered prima facie obvious over the teachings of Zuckerman.
Response to Arguments
Applicant's arguments filed 21 Jan 2026 have been fully considered but they are not persuasive. Applicant states that Zuckermann discloses methods for identifying peptoids and that the skilled artisan would be left to “vary all of the parameters to select the compounds suitable as a delivery system to a population of target cells without any reasonable expectation of success (page 19 of remarks). The examiner does not find this persuasive. Zuckerman does teach a method for screening peptoids but the examiner notes that Zukerman teaches that the peptoids are “for delivering oligonucleotides to cells” col 5 lines 46-51). Identifying the peptoids with a goal of using the peptoids for delivering oligonucleotides renders obvious a delivery vehicle composition as claimed. One of ordinary skill in the art would recognize the peptoids taught by Zuckerman for use in delivery applications as this is taught by Zuckerman.
Claim 81 is rejected under 35 U.S.C. 103 as being unpatentable over Zuckermann et al. (US 7,422,861, published 09 Sep 2008) as applied to claims 1, 5, 13, 36, 64, 84, 87, 93 and 139 above and in view of Dong et al. (WO 2016/187531, published 24 Nov 2016) as evidenced by the instant specification.
The teachings of Zuckerman are described supra.
Zuckerman does not teach the non-cationic lipid component (claim 1) and its amount (claim 13), the shielding component (claim 1) or the pegylated lipid component (claim 81). These deficiencies are made up for in the teachings of Dong.
Dong teaches lipid-like nanoparticles for delivery of polynucleotides (page 1 lines 9-11). Dong teaches that the inclusion of polyethylene glycol-lipid components such as DMG-PEG2000 provide a hydrophilic layer that increases stability of the particles (page 48 lines 15-26). The PEG-lipid components may be from 0-5% (page 48 lines 27-28). As evidenced by the instant specification, DMG-PEG2000 is a shielding component (page 3 number 10). Dong teaches the inclusion of non-cationic lipid components such as DOPE as helper lipids (page 47 lines 30-34) from about 10-40% (page 48 lines 10-14). Dong further teaches that sterols can tune particle permeability and fluidity based on it function in the cell membrane (page 49 line 7-8).
Therefore, it would have been prima facie obvious to one of ordinary skill in the
art, before the effective filing date of the claimed invention to have included a PEG-lipid component such as DMG-PEG2000 (a shielding component) from about 0-5% and a non-cationic lipid component from about 10-40% and a sterol. Dong teaches nanoparticles for delivery of polynucleotides which is similar to the delivery oligonucleotides with the peptoid components of Zuckerman. PEG-lipid components provide a hydrophilic layer that increases stability and non-cationic lipid components serve as helper lipids and sterols tune particle permeability and fluidity. Thus, it would have been obvious to one of ordinary skill to include 0-5% PEG-lipid components and 10-40% non-cationic lipids and a sterol with the peptoid components for their stabilizing, helping functions and control over permeability and fluidity.
Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, as evidenced by the references.
Response to Arguments
Applicant's arguments filed 21 Jan 2026 have been fully considered but they are not persuasive. Applicant states that Dong teaches compounds different from the cationic compounds of Zuckerman and the instant claims (page 19 of remarks). This is not persuasive as the cationic compounds of the claims are rendered obvious over Zuckerman and not Dong. Dong, however, does teach lipid like particles for delivery of polynucleotides, which is similar to the delivery of oligonucleotides taught by Zuckerman providing a connection between the teachings and rendering it obvious and providing a reasonable expectation of success to one of ordinary skill in the art to utilize features useful for the particles and delivery of polynucleotides as taught by Dong. For instance, it is known from Dong that PEG-lipid components provide a hydrophilic layer that increases stability and non-cationic lipid components serve as helper lipids and sterols tune particle permeability and fluidity and it would have been obvious to one of ordinary skill to include 0-5% PEG-lipid components and 10-40% non-cationic lipids and a sterol with the peptoid components for their stabilizing, helping functions and control over permeability and fluidity. The applicant argues that “Dong itself highlights that there is a requirement for fine-tuning of the components in the presence of particular compounds” (page 20 of remarks) but this is not persuasive against the obviousness rejection as it is expected that there would be a level of “fine-tuning” for optimal results in any combination which one of ordinary skill in the art would recognize and address. The examiner notes that a person of ordinary skill is also a person of ordinary creativity, not an automaton, and in many cases will be able to fit teachings of multiple patents together like pieces of a puzzle. Furthermore, "The test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference.... Rather, the test is what the combined teachings of those references would have suggested to those of ordinary skill in the art." In the instant case Dong provides reason for including PEG, non-cationic lipid and sterol components for polynucleotide delivery particles and it would be obvious to one of ordinary skill to incorporate the components into delivery vehicles with the peptoids of Zuckerman for their benefits.
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, 13, 36, 38, 64, 81, 84, 87, 93 and 139 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 and 15-28 of U.S. Patent No. 11,701,434 in view of Zuckermann et al. (US 7,422,861, published 09 Sep 2008) and Dong et al. (WO 2016/187531, published 24 Nov 2016) as evidenced by the instant specification.
The ‘434 patent recites a cationic peptide of formula (I).
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This formula renders obvious the cationic peptoid of instant claim 1 and formula 1e of claim 36. Claims 7-9 recite that the compound of formula (I) is complexed to a polyanionic compound. Claim 11 recites the inclusion of a nucleic acid, a phospholipid, a structural lipid and a PEG lipid. Claim 27 recites the following compound which is the same as instant compound 43, rendering obvious claim 38.
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The ’434 patent does not recite an anionic/zwitterionic component or the inclusion of a sterol or a shielding component. These deficiencies are made up for in the teachings of Zuckerman and Dong.
The teachings of Zuckerman and Dong are described supra.
Therefore, it would have been prima facie obvious to one of ordinary skill in the
art, before the effective filing date of the claimed invention to have included a lipitoid compound with a cholesterol component as taught by Zuckerman that renders obvious the anionic/zwitterionic of the instant claims as cationic peptoids, including lipitoids, are known for delivery of oligonucleotides for transfecting cells, as taught by Zuckerman. It further would have been obvious to include DMG-PEG2000 (a shielding component) from about 0-5% as it is able to provide a hydrophilic layer that increases stability. The inclusion of a component of formula (I) of the instant claims and the DMG-PEG2000 from 0-5% renders obvious instant claim 13.
Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, as evidenced by the references.
Response to Arguments
Applicant's arguments filed 21 Jan 2026 have been fully considered but they are not persuasive. Applicant states the claims of the reference patent are directed to a tertiary amino lipidated and/or PEGylated compound and thus the instant claims are distinct from the reference claims. This is not persuasive as the compounds of the reference patent render obvious the compounds of the instant claims and it is obvious to use such compounds with the additional components claimed as part of a delivery composition from the teachings of Zuckerman and Dong.
Claims 1, 5, 13, 36, 38, 64, 81, 84, 87, 93 and 139 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-24 of U.S. Patent No. 11,446,394 in view of Zuckermann et al. (US 7,422,861, published 09 Sep 2008) and Dong et al. (WO 2016/187531, published 24 Nov 2016) as evidenced by the instant specification.
The ’394 patent recites a composition with structural lipids, phospholipids, shielding lipids and compounds of formula (I) as shown below.
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Formula (I) described above renders obvious the cationic peptoids of instant claims 1 and 36, for example formula (1e) of claim 36. Claim 24 recites compounds of the same structure as compounds 41-43 of the instant claims, rendering obvious claim 38. The phospholipid may be a component such as DOPE (see claim 10), rendering obvious the non-cationic lipid component of claim 1. Claim 13 recites 40-70% cationic peptide compound, 0-25% cholesterol, 20-40% DOPE and 1-5% DMG-PEG2000, rendering obvious claims 81, 84, 87 and 13.
Thus, the instant claims are obvious over the claims of the ‘394 patent.
Response to Arguments
Applicant's arguments filed 21 Jan 2026 have been fully considered but they are not persuasive. Applicant states the claims of the reference patent are directed to compositions comprising complexes of a polyanionic compound, a phospholipid, a shielding lipid and a cationic peptide and thus the instant claims are distinct from the reference claims. This is not persuasive as the compounds of the reference patent render obvious the compounds of the instant claims and it is obvious to use such compounds with the additional components claimed as part of a delivery composition from the teachings of Zuckerman and Dong.
Claims 1, 5, 11, 13, 36, 38, 64, 81, 84, 87, 93 and 139 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3, 1,, 13, 18, 21, 26, 27, 29, 34-36, 38, 60-62, and 65-68 of copending Application No. 17/615,857 in view of Dong et al. (WO 2016/187531, published 24 Nov 2016) as evidenced by the instant specification.
The ‘857 application recites in claim 1 a composition comprising polyanionic compounds, PEG compounds, and cationic compounds of formula (Ia)
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. The structure of formula (Ia) renders obvious the cationic peptoids of instant claim 1 and formula (Ie) of claim 36. It is noted that variables n, o, q and s may be 0 and that the formula only requires R5 to be present and not R3 and R4. The R1 group may be -COH and the R7 group may be -NH2. The R5 group may be N-heteroaryl such as
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(claim 62). This renders obvious formula (Iva) of instant clam 57 where R4 is alkylheteroaryl. Claims 27 and 29 recite that the cationic compound to PEG-compound is at a ratio of 99:1 and the PEG compound is DMG-PEG2000 (a shielding component), rendering obvious instant claim 13. Claim 65 recites compounds such as compounds 41 and 112 which are the same as compounds 41 and 112 of instant claims 38 and 11.
The ’857 application does not recite phospholipids or sterols. These deficiencies are made up for in the teachings of Dong. The teachings of Dong are described supra.
Therefore, it would have been prima facie obvious to one of ordinary skill in the
art, before the effective filing date of the claimed invention to have included a sterol and a non-cationic lipid such as DOPE (a phospholipid) in the composition. It is known that non-cationic lipids serve as helper lipids and sterols are able to tune particle permability and fluidity for particles deliving polynucleotides, as taught by Dong. Thus, it would have been obvious to include DOPE and a sterol for their use as a helper lipid and to tune permeability with a target cell.
This is a provisional nonstatutory double patenting rejection.
Response to Arguments
Applicant's arguments filed 21 Jan 2026 have been fully considered but they are not persuasive. Applicant states the claims of the reference application are directed to a compositions comprising compounds, including PEG compounds, with a combined mass of at least 90% of the composition and thus the instant claims are distinct from the reference claims. This is not persuasive as the compounds of the reference application render obvious the compounds of the instant claims and it is obvious to use such compounds with the additional components claimed as part of a delivery composition from the teachings of Dong and the combination of components in the amount cited in the amount cited does not distinguish from the instant claims.
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to EDWIN C MITCHELL whose telephone number is (571)272-7007. The examiner can normally be reached Mon-Fri 8:00-5:00.
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/E.C.M./Examiner, Art Unit 1619 /ANNA R FALKOWITZ/Primary Examiner, Art Unit 1600