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 .
Status of Claims
Claims 1-20 are pending. This is the first office action on the merits.
Information Disclosure Statement
The IDSs filed 11/4/2024 (x4) have been reviewed.
Election/Restrictions
Applicant’s election of Group I (claims 1, 4, 7, 8, 11-14, 21, 29, 32-34, 62, 65, 72 and 89) without traverse in the reply dated June 29, 2026 is acknowledged. Applicant’s election of (a) the peptide encoded by SEQ ID No. 122 as the single peptide, (b) the linker covalently attached to a terminal residue of the peptide as the single covalent linkage placement, (c) a succinimdyl thioether as a single linker, (d) a reservoir kernel as a single kernel or a single combination of kernels, and (e) the non-resorbable material ePTFE as the single resorbable material without traverse in the reply dated June 29, 2026 is also noted.
Claims 11-13, 72, 112 and 114 are withdrawn as being drawn to a non-elected invention or species, there being no linking or generic claim.
Claims 1, 4, 7, 8, 14, 21, 29, 32-34, 62, 65, 80 and 89 are examined on their merits in light of the elected species of the peptide encoded by SEQ ID No. 122, the linker covalently attached to a terminal residue of the peptide, a succinimdyl thioether, a reservoir kernel, and the non-resorbable material PTFE. It is noted that SEQ ID No. 122,is an HIV-1 gp 120 V3-A peptide, which is a cell targeting peptide, as indicated in the instant specification in paragraph [404].
Claim Rejections - 35 USC §112(b)
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 4, 7, 8, 11 and 14 are rejected under 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 applicant regards as the invention.
Claim 4 is rejected under 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 applicant regards as the invention.
Claim 4 is rejected for the recitation of “the peptide” in line 1. Claim 1 recites a “cell-penetrating peptide or cell-targeting peptide” so there is insufficient antecedent basis for this limitation in the claim.
For purposes of this office action claim 4 will be interpreted as if the peptide is referring to the cell-penetrating peptide or cell-targeting peptide.
Claim 7 is rejected under 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 applicant regards as the invention.
Claim 7 is rejected for the recitation of “the peptide” in line 1. Claim 1 recites a “cell-penetrating peptide or cell-targeting peptide” so there is insufficient antecedent basis for this limitation in the claim.
For purposes of this office action claim 7 will be interpreted as if the peptide is referring to the cell-penetrating peptide or cell-targeting peptide.
Claim 8 is rejected under 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 applicant regards as the invention.
Claim 4 is rejected for the recitation of “the peptide” in line 2. Claim 1 recites a “cell-penetrating peptide or cell-targeting peptide” so there is insufficient antecedent basis for this limitation in the claim.
For purposes of this office action claim 8 will be interpreted as if the peptide is referring to the cell-penetrating peptide or cell-targeting peptide.
Claim 11 is rejected under 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 applicant regards as the invention.
Claim 11 is rejected for the recitation of “the peptide” in line 2. Claim 1 recites a “cell-penetrating peptide or cell-targeting peptide” so there is insufficient antecedent basis for this limitation in the claim.
For purposes of this office action claim 11 will be interpreted as if the peptide is referring to the cell-penetrating peptide or cell-targeting peptide.
Claim 14 is rejected under 35 U.S.C. 112 (pre-AIA ), second paragraph for reciting “comprise two or more amino acids” . . .and “preferably wherein one or more linkers comprise Gly-Ser-Gly (“GSG”)”
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) is considered indefinite, since the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). Note the explanation given by the Board of Patent Appeals and Interferences in Ex parte Wu, 10 USPQ2d 2031, 2033 (Bd. Pat. App. & Inter. 1989), as to where broad language is followed by "such as" and then narrow language. The Board stated that this can render a claim indefinite by raising a question or doubt as to whether the feature introduced by such language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims. Note also, for example, the decisions of Ex parte Steigewald, 131 USPQ 74 (Bd. App. 1961); Ex parte Hall, 83 USPQ 38 (Bd. App. 1948); and Ex parte Hasche, 86 USPQ 481 (Bd. App. 1949).
In the present instance, claim 14 recites the broad recitation “two or more amino acids”, and the claims also recite “preferably wherein one or more linkers comprise Gly-Ser-Gly (“GSG”)” which is the narrower statement of the range/limitation.
Regarding claim 14, these broad and then narrow phrases render the claim indefinite because it is unclear whether these limitations are part of the claimed invention. See MPEP § 2173.05(d). The intended scope of claim 14 is unclear because it is unclear what is called for. For the purposes of this office action claim 14 will be interpreted using the broader phrase as the limitation.
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 of this title, 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.
Claims 1, 4, 7, 8, 14, 21, 29, 32-34, 62, 65, 80 and 89 are rejected under 35 U.S.C. 103 as being unpatentable over Nairn et al. WO 2019/126240 (6/27/2019)(11/4/2024 IDS) in view of Baum et al. US 2023/0017712 (11/25/2020) and Chao WO 2016140624 (9/9/2016).
The applied reference (Baum et al) has a common inventor with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2).
This rejection under 35 U.S.C. 103 might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C.102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B); or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement. See generally MPEP § 717.02.
Nairn et al. (Nairn) teaches a drug peptide conjugate wherein the peptides are used for cell penetration or for cell targeting. (See Abstract and [01777]). Naim teaches that the peptide can be an immunopotentiating peptide as called for in instant claim 2. (See Abstract). Naim teaches that the drug peptide conjugate can be formed by direct conjugation or covalent linkage. (See [0169]). Naim teaches that the drug-peptide conjugate can contain a polymer. (See [0045]).
Naim teaches a peptide being linked at the terminal amino acid (described as the N-terminus) as called for in instant claim 8. (See Naim claim 102). Naim teaches that the peptide can be covalently linked as called for in instant claim 8. (See [0235]). Nairn teaches that its drug peptide conjugate is a peptide-immunooncology agent complex. (See [0005]).
Naim teaches that one of the examples of the functional groups for attachment is succinimidyl MCC, a succinimidyl thioether as called for in instant claim 21. (See [0290]). Succinimidyl MCC, a succinimidyl thioether, also comprises a thioether as called for in instant claim 14.
Naim teaches subcutaneous administration but does not teach a subdermal implantable device. Naim does not teach AHLPIVRASLPS (Seq ID NO. 122.) These deficiencies are made up for with the teachings of Baum et al. and Chao.
Baum et al. (Baum) teaches a sustained release drug delivery device to deliver biologically active compounds at a controlled rate for an extended period of time. The device is biocompatible and biostable and is useful as an implant in patients for the delivery of appropriate bioactive substances to tissues or organs. (See Abstract).
Baum teaches that the drug delivery device contains one or more kernels comprising an active pharmaceutical ingredient, and one or more skins comprising a continuous membrane. (See Abstract and claim 1). Baum teaches that its drug delivery device is biocompatible, biostable, implantable and able to deliver biologically active compounds at a controlled rate for an extended period of time. (See Abstract).
Baum teaches that the kernel can be a reservoir kernel that comprises a defined microscopic or nanoscopic pore structure. (See Baum claims 4 and 5). A kernel that comprises a defined microscopic or nanoscopic pore structure is called for in instant claim 32. The drug delivery device itself having pores that are microscopic or nanoscopic is called for in instant claim 80. A reservoir kernel is called for in instant claim 33. Baum teaches that the reservoir kernel can comprise a drug powder as called for in instant claim 34. (See [0234] and [0238]).
Baum also teaches that the skins can be used to regulate or control the rate of drug release from the kernel as well as the release kinetics. (See [0165]). This is a rate-limiting skin as called for in instant claim 62. Baum teaches that polytetraflurorethylene can be used as called for in instant claim 65. (See [0165] and [0114]). Baum teaches that its drug delivery devices also comprise a shape adapted to be disposed within the body of a patient as called for in instant claim 89. (See [0013]). Baum teaches that its drug delivery device is a subdermal implant drug delivery system as called for in instant claim 29.
Chao teaches isolated cytotoxic peptides. (See Abstract). Chao also teaches that the peptides are cell-targeting or cell penetrating peptides, and also teaches compositions comprising the peptides and methods of treating cancers and diseases or conditions. (See Abstract).
Chao teaches AHLPIVRASLPS in Table 2 as a useful cytotoxic cell penetrating peptide for use in targeting cancer cells. (See Table 2). PIVRASLPS
is Seq ID No. 122, that is the elected Seq ID and is called for in instant claim 7.
Chao also teaches that the cytotoxic peptides that it describes can be conjugated to a protein or an antibody by a linker. (See [0063]).
It would have been obvious to a person or ordinary skill in the art before the earliest effective filing date of the invention making the Nairn drug-peptide conjugate to place it in in a drug device containing reservoir kernels that comprise a microscopic or nanoscopic pore structure comprising a drug powder and a rate-limiting skin comprising polytetraflurorethylene and have the drug device be in a shape adapted to be disposed within the body of a patient in light of Baum’s teaching that drug device disposed within the body of a patient enables the provision of sustained, long term drug release drug delivery from a device that is biocompatible and biostable.
It would have been obvious to a person or ordinary skill in the art before the earliest effective filing date of the invention making the Nairn drug-peptide conjugate to use AHLPIVRASLPS as the peptide in light of Chao’s teaching that it is a useful cell penetrating peptide for treating cancer due to its cytotoxicity.
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, 4, 7, 8, 14, 21, 29, 32-34, 62, 65, 80 and 89 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4-6, 14-15, 29, 34-35, 37, 39 and 92 of copending Application No. 17/780420 in view of Nairn et al. WO 2019/126240 (6/27/2019)(11/4/2024 IDS) and Chao WO 2016140624 (9/9/2016)..
Claim(s) 1, 4, 7, 8, 14, 21, 29, 32-34, 62, 65, 80 and 89 are directed to an invention not patentably distinct from claims 1, 4-6, 14-15, 29, 34-35, 37, 39 and 92 of commonly assigned Application No. 17/780420.
Although the claims at issue are not identical, they are not patentably distinct from each other because both the instant claims and that of Application ‘145 are directed to a drug delivery device comprising one or more reservoir kernels, one or more skin comprising a continuous membrane which have defined pores.
The instant invention is directed to a drug delivery device comprising one or more peptide-drug conjugates, wherein the drug delivery device comprising one or more reservoir kernels comprising the one or more peptide-drug conjugates that is a cell-penetrating immunopotentiating peptide covalently linked to one or more drugs via covalent linkers, and one or more skins comprising a continuous membrane which may be polytetraflurorethylene.
Application ‘420 is directed to a drug delivery device comprising one or more active pharmaceutical ingredients, wherein the drug delivery device comprising one or more reservoir kernels comprising the active pharmaceutical ingredients in powder form, and one or more skins comprising a continuous membrane which may be polytetraflurorethylene.
Application ‘420 does not teach peptide-drug conjugates that are a cell-penetrating immunopotentiating peptide covalently linked to one or more drugs via covalent linkers or peptide AHLPIVRASLPS. These teachings are made up for with the teachings of Nairn and Chao.
The teachings of Nairn are described supra. It would have been obvious to a person of ordinary skill in the art before the earliest effective filing date of the invention making the drug device of the ‘420 Application to have the active pharmaceutical agent be one or more peptide-drug conjugates that is a cell-penetrating immunopotentiating peptide covalently linked to one or more drugs via the succinimidyl MCC covalent linker at the terminal amino acid as taught by Nairn in order to have the active pharmaceutical agent be a peptide-immunooncology agent complex that can combat cancer.
The teachings of Ahmad are described supra. It would have been obvious to a person of ordinary skill in the art before the earliest effective filing date of the invention making the drug device of the ‘420 Application to use AHLPIVRASLPS as the peptide in light of Chao’s teaching that it is a useful cell penetrating cytotoxic peptide for treating cancer.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1, 4, 7, 8, 14, 21, 29, 32-34, 62, 65, 80 and 89 are directed to an invention not patentably distinct from claims 1, 4-6, 14-15, 29, 34-35, 37, 39 and 92 of commonly assigned copending Application No. 17/780420 in view of Nairn et al. WO 2019/126240 (6/27/2019)(11/4/2024 IDS) and Chao WO 2016140624 (9/9/2016).. Specifically, see above.
The U.S. Patent and Trademark Office may not institute a derivation proceeding in the absence of a timely filed petition. The USPTO normally will not institute a derivation proceeding between applications or a patent and an application having common ownership (see 37 CFR 42.411). Commonly assigned U.S. Patent Appn. No. 17/780420, discussed above, may form the basis for a rejection of the noted claims under 35 U.S.C. 102 or 103 if the commonly assigned case qualifies as prior art under 35 U.S.C. 102(a)(2) and the patentably indistinct inventions were not commonly owned or deemed to be commonly owned not later than the effective filing date under 35 U.S.C. 100(i) of the claimed invention.
In order for the examiner to resolve this issue the applicant or patent owner can provide a statement under 35 U.S.C. 102(b)(2)(C) and 37 CFR 1.104(c)(4)(i) to the effect that the subject matter and the claimed invention, not later than the effective filing date of the claimed invention, were owned by the same person or subject to an obligation of assignment to the same person. Alternatively, the applicant or patent owner can provide a statement under 35 U.S.C. 102(c) and 37 CFR 1.104(c)(4)(ii) to the effect that the subject matter was developed and the claimed invention was made by or on behalf of one or more parties to a joint research agreement that was in effect on or before the effective filing date of the claimed invention, and the claimed invention was made as a result of activities undertaken within the scope of the joint research agreement; the application must also be amended to disclose the names of the parties to the joint research agreement.
A showing that the inventions were commonly owned or deemed to be commonly owned not later than the effective filing date under 35 U.S.C. 100(i) of the claimed invention will preclude a rejection under 35 U.S.C. 102 or 103 based upon the commonly assigned case. Alternatively, applicant may take action to amend or cancel claims such that the applications, or the patent and the application, no longer contain claims directed to patentably indistinct inventions.
Claims 1, 4, 7, 8, 14, 21, 29, 32-34, 62, 65, 80 and 89 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 14-15, 18-20, 27-30, 37 and 39 of copending Application No. 17/766860 in view of Nairn et al. WO 2019/126240 (6/27/2019)(11/4/2024 IDS) and Chao WO 2016140624 (9/9/2016).
Claim(s) 1, 4, 7, 8, 14, 21, 29, 32-34, 62, 65, 80 and 89 are directed to an invention not patentably distinct from claims 1, 14-15, 18-20, 27-30, 37 and 39 of commonly assigned Application No. 17/766860.
Although the claims at issue are not identical, they are not patentably distinct from each other because both the instant claims and that of Application ‘860 are directed to a drug delivery device comprising one or more reservoir kernels, one or more skin comprising a continuous membrane which have defined pores.
The instant invention is directed to a drug delivery device comprising one or more peptide-drug conjugates, wherein the drug delivery device comprising one or more reservoir kernels which have defined pores comprising the one or more peptide-drug conjugates that is a cell-penetrating immunopotentiating peptide covalently linked to one or more drugs via covalent linkers, and one or more skins comprising a continuous membrane which may be polytetraflurorethylene.
Application ‘860 is directed to a drug delivery device comprising one or more active pharmaceutical ingredients, wherein the drug delivery device comprising one or more reservoir kernels comprising the active pharmaceutical ingredients in powder form, and one or more skins comprising a continuous membrane which may be polytetraflurorethylene.
Application ‘860 does not teach peptide-drug conjugates that are a cell-penetrating immunopotentiating peptide covalently linked to one or more drugs via covalent linkers or peptide AHLPIVRASLPS. These teachings are made up for with the teachings of Nairn and Chao.
The teachings of Nairn are described supra. It would have been obvious to a person of ordinary skill in the art before the earliest effective filing date of the invention making the drug device of the ‘860 Application to have the active pharmaceutical agent be one or more peptide-drug conjugates that is a cell-penetrating immunopotentiating peptide covalently linked to one or more drugs via the succinimidyl MCC covalent linker at the terminal amino acid as taught by Nairn in order to have the active pharmaceutical agent be a peptide-immunooncology agent complex that can combat cancer.
The teachings of Ahmad are described supra. It would have been obvious to a person of ordinary skill in the art before the earliest effective filing date of the invention making the drug device of the ‘860 Application to use AHLPIVRASLPS as the peptide in light of Chao’s teaching that it is a useful cell penetrating cytotoxic peptide for treating cancer.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1, 4, 7, 8, 14, 21, 29, 32-34, 62, 65, 80 and 89 are directed to an invention not patentably distinct from claims 1, 14-15, 18-20, 27-30, 37 and 39 of commonly assigned copending Application No. 17/766860 in view of Nairn et al. WO 2019/126240 (6/27/2019)(11/4/2024 IDS) and Chao WO 2016140624 (9/9/2016). Specifically, see above.
The U.S. Patent and Trademark Office may not institute a derivation proceeding in the absence of a timely filed petition. The USPTO normally will not institute a derivation proceeding between applications or a patent and an application having common ownership (see 37 CFR 42.411). Commonly assigned U.S. Patent Appn. No. 17/766860, discussed above, may form the basis for a rejection of the noted claims under 35 U.S.C. 102 or 103 if the commonly assigned case qualifies as prior art under 35 U.S.C. 102(a)(2) and the patentably indistinct inventions were not commonly owned or deemed to be commonly owned not later than the effective filing date under 35 U.S.C. 100(i) of the claimed invention.
In order for the examiner to resolve this issue the applicant or patent owner can provide a statement under 35 U.S.C. 102(b)(2)(C) and 37 CFR 1.104(c)(4)(i) to the effect that the subject matter and the claimed invention, not later than the effective filing date of the claimed invention, were owned by the same person or subject to an obligation of assignment to the same person. Alternatively, the applicant or patent owner can provide a statement under 35 U.S.C. 102(c) and 37 CFR 1.104(c)(4)(ii) to the effect that the subject matter was developed and the claimed invention was made by or on behalf of one or more parties to a joint research agreement that was in effect on or before the effective filing date of the claimed invention, and the claimed invention was made as a result of activities undertaken within the scope of the joint research agreement; the application must also be amended to disclose the names of the parties to the joint research agreement.
A showing that the inventions were commonly owned or deemed to be commonly owned not later than the effective filing date under 35 U.S.C. 100(i) of the claimed invention will preclude a rejection under 35 U.S.C. 102 or 103 based upon the commonly assigned case. Alternatively, applicant may take action to amend or cancel claims such that the applications, or the patent and the application, no longer contain claims directed to patentably indistinct inventions.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARAH CHICKOS whose telephone number is (571)270-3884. The examiner can normally be reached on M-F 9-6.
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SARAH CHICKOS
Examiner
Art Unit 1619
/DAVID J BLANCHARD/Supervisory Patent Examiner, Art Unit 1619
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