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 .
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1-8, drawn to a method of treating non-alcoholic steatohepatitis (NASH) in a subject, in the reply filed on 9/8/2026 is acknowledged.
Claim Status
Claims 1-20 are pending. Claims 9-20 are hereby withdrawn as non-elected inventions.
Priority
The instant application is a continuation of 17/223,881, filed 4/6/2021, which claims priority to the provisional application 63/005,867 filed 4/6/2020. The priority date of 4/6/2020 is acknowledged.
Drawings
The drawings are objected to for the following reasons:
1. The drawings are too small and blurry to interpret: Figures 1A, 1B, 2A-2D, 3A-4E, 6B-6E, 18, 23E (second page), 26B, 26D, 26E; for instance, see part of 1A below:
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2. There are no Y-axis labels: Figures 4B-4E, 6B-6E, 7A-7D, and 11A (left panel).
3. Colored images now in grayscale are difficult to interpret: Figures 5B-E, 6A, 6F (first panel of images), 6G (first panel of images), 8 (the red arrows measuring the livers cannot be seen), 9A-9C, 10A-10E, 14, 19A, 20A, 21A, 22A, 23A (upper and middle images), 23B, 23D (upper most images), 23E (upper image), 23F (upper image), 24A (upper image), 24B (upper image), 24C (upper image), 25A (first page and second page, upper panel), 25B (middle image), and 35C (first, second, and third pages, upper images).
4. The figures are missing keys to distinguish one group from another: Figures 15-17, 20B, and 21B.
5. Other: In Figure 19B, in the graph on right, the final column appears to be missing (only the error bar can be seen). Figure 22B has the same issues.
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.
Color photographs and color drawings are not accepted in utility applications unless a petition filed under 37 CFR 1.84(a)(2) is granted. Any such petition must be accompanied by the appropriate fee set forth in 37 CFR 1.17(h), one set of color drawings or color photographs, as appropriate, if submitted via the USPTO patent electronic filing system or three sets of color drawings or color photographs, as appropriate, if not submitted via the via USPTO patent electronic filing system, and, unless already present, an amendment to include the following language as the first paragraph of the brief description of the drawings section of the specification:
The patent or application file contains at least one drawing executed in color. Copies of this patent or patent application publication with color drawing(s) will be provided by the Office upon request and payment of the necessary fee.
Color photographs will be accepted if the conditions for accepting color drawings and black and white photographs have been satisfied. See 37 CFR 1.84(b)(2).
6. Figures 12, 13A, 13B, and 26A should be designated by a legend such as --Prior Art-- because only that which is old is illustrated. See MPEP § 608.02(g). Corrected drawings in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. The replacement sheet(s) should be labeled “Replacement Sheet” in the page header (as per 37 CFR 1.84(c)) so as not to obstruct any portion of the drawing figures. 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 it contains an embedded hyperlink and/or other form of browser-executable code (see [00176]). 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://, www, or other browser-executable code. See MPEP § 608.01.
The use of the terms GRAPHPAD PRISM ([00113, 00125, 00174, 00175, 00176, 00183 (two instances)]), ECHOMRI ([00113]), TSQ QUANTUM ULTRA ([00122]), XCLAIBUR ([00122]), RNEASY ([00126]), SUPERSCRIPT II ([00126]), LIGHTCYCLER 480 SYBR GREEN I MASTER ([00126 (two instances)]), BIOMOL ([00126]), CLICK-IT ([00133, 00174]), VECTASHIELD ([00178 (two instances), 00181, 00182]), VECTAMOUNT ([00178, 00182]), TRITON-X100 ([00177 (two instances), 00178, 00182]) which are trade names or marks used in commerce, have been noted in this application. The terms should be accompanied by the generic terminology; furthermore the terms should be capitalized wherever they appear or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Claim Interpretation
1. Claim 1 recites a method for treating non-alcoholic steatohepatitis. The limitation “for
treating non-alcoholic steatohepatitis” is being interpreted as an intended use.
2. Claims 7 and 8 recite functional outcomes that arise as a consequence of performing
the method of claim 1. As such, the claims are being interpreted based upon the structural limitations of claim 1.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
1. Claims 1-8 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The claims are drawn to a method for treating non-alcoholic steatohepatitis (NASH) comprising administering a polypeptide antagonist of a Na/K-ATPase/Src receptor complex to a subject in need thereof. The only polypeptide antagonist disclosed is SEQ ID NO: 5 (Examples 1, 4, 6, and 7).
Further, in certain embodiments, the polypeptide antagonist is SEQ ID NO: 1 or SEQ ID NO: 5 or a functional fragment and/or variant thereof. The instant specification defines the terms “fragment” and “variant” in [0064] and [0065], respectively. The definitions permit substitutions, additions, and deletions at every amino acid position in SEQ ID NO: 1 as well as fragmentation. Therefore, the claims encompass any and all fragments and/or variants of SEQ ID NO: 1 that can antagonize Na/K-ATPase/Src receptor complex sufficient to treat NASH.
Thus, the claims are drawn to both the genera of polypeptide antagonists of Na/K-ATPase/Src receptor complex as well as fragments or functional variants of SEQ ID NO: 1 or 5. However, the claimed genera do not disclose sufficient structure-function relationship to meet the written description requirement as there is only written description support for administration of SEQ ID NO: 1 or SEQ ID NO: 5.
The instant specification teaches that SEQ ID NO: 5 treats NASH by blocking Src phosphorylation at the α1-subunit of Na/K-ATPase ([0062]). Therefore, a claimed functional fragment or variant of SEQ ID NO: 1 or SEQ ID NO: 5 would be required to retain this function. However, the exact residues by which SEQ ID NO: 5 blocks Src phosphorylation are unknown and not disclosed. This would make it extremely difficult for one of ordinary skill in the art to readily make and use SEQ ID NO: 5 fragments or variants to practice the claimed methods.
Kelly et al. (US 20060058228, published 3/16/2006) discusses a phage display screen to identify peptides that distinguish between well-differentiated (HCT116) and poorly-differentiated (HT29) colon cancer cell lines. Analysis of the selected library resulted in the identification of a nine amino acid, disulfide-constrained peptide having a three amino acid (arg-pro-met, “RPM”) motif that specifically binds HT29 cells ([0032]). Substituting each of RPM with alanine significantly limited or abolished the ability of the peptide to compete with wild type RPM in a binding assay, indicating that these three residues alone accounted for the ability to bind to HT29 cells ([0034]). In contrast to this example, the key residues that mediate inhibition of Src phosphorylation to treat NASH are unknown; therefore, it would be nearly impossible for one of ordinary skill in the art to extrapolate how alterations to any amino acid in SEQ ID NO: 5 might impact its functionality.
Further, Guo (Protein tolerance to random amino acid change, Proc. Natl. Acad. Sci. U.S.A. 101 (25) 9205-9210, (2004).) teaches that a protein’s tolerance to random substitutions ultimately depends on whether the residues at hand are involved the protein’s functional activity. For instance, regions that were highly substitutable in the human DNA repair enzyme 3-methyladenine DNA glycosylase (AAG) include the first 79 N-terminal residues previously demonstrated to be unnecessary for in vitro enzyme activity and DNA binding specificity. In contrast, residues that are involved in glycosylase function or DNA binding did not tolerate amino acid substitutions (“Substitutability and Structure”, Pg 9207-9209; Figure 1). Figure 1 of Guo also indicates that tolerated substitutions are generally conservative, i.e., a nonpolar residue is substituted for another nonpolar residue, etc. However, there are no explicit limitations in the instant claims regarding the sequence and/or structural similarity that the claimed fragments or variants must have.
Consequently, the instant specification does not provide adequate written description to possess the broad genus claimed because the specification does not disclose a correlation between the necessary structure of the sequence and the claimed function to be maintained.
2. Claims 1-8 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for a method of treatment of NASH, does not reasonably provide enablement for a method of prevention of NASH. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
The Applicant’s attention is drawn to In re Wands, 8 USPQ2d 1400 (CAFC1988) at 1404 where the court set forth eight factors to consider when assessing if a disclosure would have required undue experimentation. Citing Ex parte Forman, 230 USPQ 546 (BdApls 1986) at 547 the court recited eight factors:
(1) The nature of the invention; (2) the state of the prior art; (3) the relative skill of those in the art; (4) the predictability or unpredictability of the art; (5) the breadth of the claims; (6) the amount of direction or guidance presented; (7) the presence or absence of working examples; and (8) the quantity of experimentation necessary.
1) Nature of the invention and 5) breadth of the claims: The claims are drawn to a method for treating non-alcoholic steatohepatitis (NASH) comprising administering a polypeptide antagonist of a Na/K-ATPase/Src receptor complex to a subject in need thereof; in certain embodiments, the polypeptide antagonist is SEQ ID NO: 1 or SEQ ID NO: 5 or a functional fragment and/or variant thereof.
The instant specification defines treatment as the medical management of a subject with the intent to cure, ameliorate, stabilize, or prevent a disease, pathological condition, or disorder; further, this term includes treatment directed to minimizing or partially or completely inhibiting the development of the associated disease, pathological condition, or disorder ([0070]). Thus, treatment as claimed effectively includes prevention, where prevention reads on administering a polypeptide antagonist of Na/K-ATPase/Src receptor complex to any individual with or without an NASH.
2) State of the prior art and 4) predictability or unpredictability of the art: The art at the time of filing only recognized diet and exercise as preventative measures for NASH (Trovato et al. Nonalcoholic fatty liver disease (NAFLD) prevention: role of Mediterranean diet and physical activity. Hepatobiliary Surg Nutr. 2019 Apr;8(2):167-169.).
Consequently, one skilled in the art would reasonably predict that administering a polypeptide antagonist of Na/K-ATPase/Src receptor complex would not prevent NASH.
3) The relative skill of those in the art: The relative skill of those in the art is high.
6) The amount of direction or guidance presented: At the time of filing, no direction or
guidance was presented in either the prior art or the instant specification that would enable one to polypeptide antagonist of Na/K-ATPase/Src receptor complex to prevent NASH as claimed.
7) The presence or absence of working examples: The instant specification provides
no examples wherein a polypeptide antagonist of Na/K-ATPase/Src receptor complex or SEQ ID NO: 5 is administered prior to the onset of NASH to prevent its manifestation.
8) The quantity of experimentation necessary: As there are no working examples in
either the instant specification nor the prior art, reasonable guidance with respect to preventing NASH through administration of Na/K-ATPase/Src receptor complex or SEQ ID NO: 5 was limited. Consequently, one skilled in the art would be burdened with undue experimentation to determine the precise parameters and conditions necessary to effectively prevent NASH.
Therefore, in view of the Wands factors, as discussed above, Applicants fail to provide sufficient information to practice the claimed invention.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
1. Claim(s) 1-8 are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Xie (US20180353569A1, published 12/13/2018).
Xie teaches methods for treating obesity or reducing adiposity and adipogenesis comprising administering a polypeptide antagonist of a Na/K ATPase/Src receptor complex to a subject in need thereof (Abstract).
Regarding claims 1, 7, and 8, Xie teaches and claims a method for treating obesity, comprising administering a polypeptide antagonist of a Na/K ATPase/Src receptor complex to a subject in need thereof (claim 1). As stated above in the Claim Interpretation section, the limitation “for treating non-alcoholic steatohepatitis” is being interpreted as an intended use. Consequently, because Xie teaches the same active step as the instant claim 1, Xie anticipates the instant claim 1. Per MPEP 2112(I): "[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer." Atlas Powder Co. v. IRECO Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977).
Regarding claim 2, Xie claims the polypeptide antagonist comprises the sequence of SEQ ID NO: 1, or a fragment, and/or variant thereof; SEQ ID NO: 1 of Xie is identical to the instant SEQ ID NO: 1 (claim 2).
Regarding claim 3, Xie claims the polypeptide antagonist further includes a cell penetrating polypeptide encoded by an amino acid sequence selected from the group consisting of SEQ ID NOS: 2-3, which are identical to the instant SEQ ID NO: 2 and 3, respectively (claim 3). Xie also teaches yet another exemplary leader (cell penetrating peptide) sequence includes an amino acid sequence encoding the N-terminal poly-lysine domain of the α1 subunit of Na/K-ATPase (AlN), which is represented by the sequence of SEQ ID NO: 4 (KKGKKGKK); SEQ ID NO: 4 of Xie is identical to the instant SEQ ID NO: 4 ([0041]).
Regarding claim 4, Xie teaches SEQ ID NO: 5, which is identical to the instant SEQ ID NO: 5 ([0041]).
Regarding claim 5, Xie teaches and claims administering step includes oral administration, transdermal administration, administration by inhalation, nasal administration, topical administration, intraaural administration, rectal administration, intravenous administration, intramuscular administration, subcutaneous administration, intravitreous administration, or combinations thereof (claim 4).
Regarding claim 6, Xie teaches the subject can be human ([0059]).
2. Claim(s) 1-4, 7, and 8 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Pratt et al. (Mechanistic Insight of Na/K-ATPase Signaling and HO-1 into Models of Obesity and Nonalcoholic Steatohepatitis. Int. J. Mol. Sci. 2019, 21, 87.), as evidenced by Wang et al. (Sodium potassium adenosine triphosphatase (Na/K-ATPase) as a therapeutic target for uremic cardiomyopathy. Expert Opin Ther Targets. 2017 May;21(5):531-541.).
Pratt teaches obesity is a multifaceted pathophysiological condition that has been associated with lipid accumulation, adipocyte dysfunction, impaired mitochondrial biogenesis and an altered metabolic profile. Redox imbalance and excessive release of inflammatory mediators have been intricately linked in obesity-associated phenotypes. Hence, understanding the mechanisms of redox signaling pathways and molecular targets exacerbating oxidative stress is crucial in improving health outcomes. The activation of Na/K-ATPase/Src signaling, and its downstream pathways, by reactive oxygen species (ROS) has been recently implicated in obesity and subsequent nonalcoholic steatohepatitis (NASH), which causes further production of ROS creating an oxidant amplification loop (Abstract; Figure 1).
Regarding claims 1-4, 7, and 8, Pratt teaches pNaKtide is an antagonist of the scaffolding function of Na/K-ATPase signaling, which is equivalent to the instant SEQ ID NO: 5 as evidenced by Wang (see Pg 10, “5. Development of pNaKtide”). Pratt states that the administration of pNaKtide in murine models of steatohepatitis showed marked reduction in protein carbonylation along with significantly reduced inflammatory markers, lipid accumulation, improved insulin resistance and mitochondrial fatty acid oxidation (treating NASH; Pg 8, “6. Approaches to targeted inhibition of the Na/K-ATPase oxidant implication loop”).
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.
1. Claims 1-8 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 of U.S. Patent No. 8,981,051 B2 (US ‘051). Although the claims at issue are not identical, they are not patentably distinct from each other because practicing the instant method steps reads on the claims of US ‘051.
2. Claims 1-3 and 5-8 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3 and 6 of U.S. Patent No. 9,226,952 B2 (US ‘952). Although the claims at issue are not identical, they are not patentably distinct from each other because practicing the instant method steps reads on the claims of US ‘952.
3. Claims 1-8 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3 of U.S. Patent No. 9,663,561 B2 (US ‘561). Although the claims at issue are not identical, they are not patentably distinct from each other because practicing the instant method steps reads on the claims of US ‘561 and vice versa.
4. Claims 1-8 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of U.S. Patent No. 10,973,867 B2 (US ‘867). Although the claims at issue are not identical, they are not patentably distinct from each other because practicing the instant method steps reads on the claims of US ‘867 and vice versa.
5. Claims 1-8 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5 of U.S. Patent No. 11,865,162 B2 (US ‘162). Although the claims at issue are not identical, they are not patentably distinct from each other because practicing the instant method steps reads on the claims of US ‘162 and vice versa.
6. Claims 1-8 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of U.S. Patent No. 11,220,528 B2 (US ‘528). Although the claims at issue are not identical, they are not patentably distinct from each other because practicing the instant method steps reads on the claims of US ‘528 and vice versa.
7. Claims 1-8 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of U.S. Patent No. 11,311,600 B2 (US ‘600). Although the claims at issue are not identical, they are not patentably distinct from each other because practicing the instant method steps reads on the claims of US ‘600 and vice versa.
8. Claims 1-8 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7 of U.S. Patent No. 11,958,915 B2 (US ‘915). Although the claims at issue are not identical, they are not patentably distinct from each other because practicing the instant method steps reads on the claims of US ‘915 and vice versa.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Sara Konopelski Snavely whose telephone number is (571)272-1841. The examiner can normally be reached Monday - Friday 9-6pm EST.
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/SARA E KONOPELSKI SNAVELY/Examiner, Art Unit 1658
/Melissa L Fisher/Supervisory Patent Examiner, Art Unit 1658
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