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
The present Office action is responsive to the Preliminary Amendment filed on 06-08-2023. As directed, claims 3-15 have been amended, no claims have been canceled, and new claims 16-20 have been added. Thus, claims 1-20 are currently pending examination.
Claim Objections
Claims 1-2, 9, and 19 are objected to because of the following informalities:
At claim 1, line 6, it is suggested that “the first and second ends” be replaced with “the first end and the second end” for clarity.
At claim 2, line 2, it is suggested that “the first and second ends” be replaced with “the first end and the second end” for clarity.
At claim 9, line 2, it is suggested that “the” be added before “capsule” for clarity.
At claim 13, line 2, it is suggested that “tubular” be deleted from the claim, as only “body” has antecedent basis in claim 1.
At claim 19, line 1, it is suggested that “the” be added before “capsule” for clarity.
Appropriate correction is required.
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 3 and 15-16 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.
Regarding claim 3, lines 2-3 recite “and the capsule receptacle has a diameter that is no more than 25 % of the capsule diameter” which renders the claim indefinite. Claim 1 outlines that the capsule is to be disposed within the capsule receptable at lines 2-4. It is therefore unclear how the capsule could possibly be disposed within the capsule receptacle if the diameter of the receptacle is at most one-fourth of the diameter of the capsule.
Pursuant to the specification at page 3, lines 13-14, page 12, lines 10-12, and page 16, lines 9-11, the limitation will be interpreted such that the diameter of the capsule receptable is up to 25% greater than the capsule diameter.
Applicant is encouraged to amend the claims in accordance with this interpretation, or else clarify how the capsule, with its claimed larger diameter as compared to the receptacle, is fit into the receptacle.
Regarding claim 15, line 2 positively recites “the mouthpiece element” which lacks antecedent basis in claim 1 from which claim 15 depends. However, claim 14 includes antecedent basis for the claim term, and thus it is unclear if claim 15 is meant to depend from claim 1 or from claim 15.
The claim will be interpreted to depend from claim 14 to give the cited element proper antecedent basis. Applicant is encouraged to amend the claims in the same manner to overcome the rejection.
Regarding claim 16, lines 2-3 recite “and the capsule receptacle has a diameter that is no more than 25 % of the capsule diameter” which renders the claim indefinite. Claim 1 outlines that the capsule is to be disposed within the capsule receptable at lines 2-4. It is therefore unclear how the capsule could possibly be disposed within the capsule receptacle if the diameter of the receptacle is at most one-fourth of the diameter of the capsule.
Pursuant to the specification at page 3, lines 13-14, page 12, lines 10-12, and page 16, lines 9-11, the limitation will be interpreted such that the diameter of the capsule receptable is up to 25% greater than the capsule diameter.
Applicant is encouraged to amend the claims in accordance with this interpretation, or else clarify how the capsule, with its claimed larger diameter as compared to the receptacle, is fit into the receptacle.
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 non-obviousness.
Claims 1-2, 4-5, 8-9, 13, 17, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Alston (US 2004/0206350) in view of Dunne (US 2014/0182587).
Regarding claim 1, Alston discloses an inhaler article (100) (paragraph 23, lines 1-2 and 10-14; Fig. 1A) comprising:
a body (105) comprising an upstream end and a downstream end (paragraph 23, lines 3-5; see annotated Fig. 1A below), a capsule receptacle (110), and an airflow path extending from the capsule receptacle (110) to an opening (145) at the downstream end (paragraph 23, lines 3-5 and 10-14; paragraph 25, lines 1-4, see arrows 155 and 160; Fig. 1A); and
a capsule (125) disposed inside the capsule receptacle (110) (paragraph 23, lines 5-7; paragraph 22, lines 1-4; Fig. 1A), the capsule (125) comprising:
a first end and a second end (see annotated Fig. 1A below);
a tubular side wall extending between the first and second ends (see annotated Fig. 1A below for first and second ends; see Figs. 1A-C for the lateral dimension of the capsule 125, and Figs. 2A-B for the circular cross-section, given that the cross-section is circular, and the capsule extends into the plane of the page in Figs. 2A-B, the capsule is regarded as tubular, and the tubular side wall is defined as the circular boundary of the capsule extending form the first end to the second end);
only a single aperture (130) in the capsule (125) (paragraph 23, lines 7-10; Fig. 1A); and
an inhalable powder disposed inside the capsule (125) (paragraph 23, lines 7-10; paragraph 22, lines 4-8),
wherein the first end of the capsule (125) is oriented toward the upstream end of the body, and wherein the single aperture (130) is disposed closer to the first end than the second end (see annotated Fig. 1A below, where the first end of the capsule coincides with the upstream end, and the single aperture 130 is disposed at the first end and is therefore closer to the first end than the second end).
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Because Alston incorporates the aperture at the first end, Alston fails to disclose the single aperture extending through the tubular side wall, since the tubular side wall is defined as extending between the first and second ends.
However, Dunne teaches a capsule (1+2) for an inhaler article (abstract, lines 1-4; paragraph 80, lines 1-3; Fig. 1A), wherein an aperture (6) is located in a tubular side wall of the capsule (1+2) (paragraph 36, lines 1-7, see cylindrical; paragraph 80, lines 1-5; Figs. 1A-C), wherein the size, position, and number of holes is variable in order to optimize the capsule structure for particular powders to be nebulized based on their flow simulations (paragraph 36, lines 7-14; note also, paragraph 13, lines 7-9, where a single aperture arrangement is contemplated).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the placement of the single aperture of the Alston capsule to be oriented in the tubular side wall closer to the first end of the capsule, given that Alston contemplates the aperture at the first end while Dunne contemplates the aperture in the side wall of its capsule, as Dunne teaches that the placement of an aperture within a capsule for dispelling inhalable powder may be variably modified in order to optimize the nebulization of the powder within the capsule.
Regarding claim 2, Alston in view of Dunne disclose the inhaler article of claim 1, as discussed above.
Alston further discloses wherein each of the first and second ends comprises a hemisphere (refer to annotated Fig. 1A above for the first and second ends; note in Fig. 1A, the first and second ends are half circles, and thus hemispherical).
Regarding claim 4, Alston in view of Dunne disclose the inhaler article of claim 1, as discussed above.
Modified Alston fails to explicitly disclose wherein the single aperture is within 2 mm to within 10 mm of the first end as measured along a longitudinal axis of the capsule.
However, Dunne teaches that the position of the aperture in the capsule is “very variable” in its design in order to produce optimized aperture structures in the capsule relative to a particular powder encased within the capsule (paragraph 36, lines 7-14).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the placement of the single aperture of modified Alston to be within 2 mm to within 10 mm of the first end as measured along a longitudinal axis of the capsule, given that Dunne teaches that optimized nebulization of different preparations and/or powders can be accommodated by varying the position of the aperture. Further, given that Applicant places no criticality on the claimed range, stating only that the single aperture may be positioned in the given range without supporting evidence as to why the range is necessary or produces an unexpected result (page 2, line 32-page 3, line 4; page 9, lines 4-9; page 12, lines 13-15; and page 15, lines 8-12), the courts have concluded that “”[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955); MPEP 2144.05.II). In this case, Dunne teaches the ordinarily skilled artisan that modifying the aperture position can be used to routinely optimize the nebulization of powder within a capsule. Thus, finding the workable ranges for optimizing the powder nebulization is not inventive, given Dunne’s teaching.
Regarding claim 5, Alston in view of Dunne disclose the inhaler article of claim 1, as discussed above.
Presently modified Alston fails to disclose wherein the single aperture has an area of 0.2 mm2 to 1.5 mm2.
However, Dunne further teaches an aperture area of 0.196 mm2 to 1.766 mm2 (paragraph 117, lines 7-10, where the range of hole diameter of 0.5-1.5 mm, using the area of a circle as A=(pi)r2, results in an area of roughly 0.196 mm2 to 1.766 mm2, where the respective radii are 0.25 mm and 0.75 mm).
In the case where the range taught in the prior art overlaps or lies inside of that of the claim, a prima facie case of obviousness exists (see MPEP 2144.05.I, and In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990)).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have chosen aperture areas in the range of 0.196 mm2 to 1.766 mm2, as taught by Dunne, as a known area size for the aperture within a capsule for dispersion of powder with a reasonable expectation of success. This range overlaps that which is claimed, and is therefore prima facie obvious.
Regarding claim 8, Alston in view of Dunne disclose the inhaler article of claim 1, as discussed above.
Alston further discloses wherein the inhalable powder comprises flavor particles (paragraph 45, lines 1-2).
Regarding claim 9, Alston in view of Dunne disclose the inhaler article of claim 1, as discussed above.
Alston further discloses wherein the capsule (125) is a polymeric capsule (paragraph 31, lines 12-13).
Regarding claim 13, Alston in view of Dunne disclose the inhaler article of claim 1, as discussed above.
Alston further discloses wherein the upstream end of the body (105) forms a distal end of the capsule receptacle (110) (see Fig. 1A, and its annotated version above, where the distal end of the chamber 110 can be defined as the area of the chamber 110 disposed distal to opening 145, which is situated at the upstream end of the body 105).
Regarding claim 17, Alston in view of Dunne disclose the inhaler article of claim 2, as discussed above.
Modified Alston fails to explicitly disclose wherein the single aperture is within 2 mm to within 10 mm of the first end as measured along a longitudinal axis of the capsule.
However, Dunne teaches that the position of the aperture in the capsule is “very variable” in its design in order to produce optimized aperture structures in the capsule relative to a particular powder encased within the capsule (paragraph 36, lines 7-14).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the placement of the single aperture of modified Alston to be within 2 mm to within 10 mm of the first end as measured along a longitudinal axis of the capsule, given that Dunne teaches that optimized nebulization of different preparations and/or powders can be accommodated by varying the position of the aperture. Further, given that Applicant places no criticality on the claimed range, stating only that the single aperture may be positioned in the given range without supporting evidence as to why the range is necessary or produces an unexpected result (page 2, line 32-page 3, line 4; page 9, lines 4-9; page 12, lines 13-15; and page 15, lines 8-12), the courts have concluded that “”[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955); MPEP 2144.05.II). In this case, Dunne teaches the ordinarily skilled artisan that modifying the aperture position can be used to routinely optimize the nebulization of powder within a capsule. Thus, finding the workable ranges for optimizing the powder nebulization is not inventive, given Dunne’s teaching.
Regarding claim 19, Alston in view of Dunne disclose the inhaler article of claim 2, as discussed above.
Alston further discloses wherein the capsule (125) is hydroxypropyl methylcellulose (paragraph 31, lines 9-11).
Claims 3 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Alston (US 2004/0206350) in view of Dunne (US 2014/0182587), as applied to claims 1-2 above, in further view of Zuber (WO 2019/003118).
Regarding claim 3, Alston in view of Dunne disclose the inhaler article of claim 1, as discussed above.
Examiner notes that claim 3 is rejected and interpreted in light of the rejection under 35 USC 112(b) above.
While Alston illustrates that the capsule receptable diameter is larger than the capsule diameter (see Figs. 2A-B), modified Alston fails to explicitly disclose wherein the capsule receptacle has a diameter that is no more than 25% greater than the capsule diameter.
However, Zuber teaches a capsule cavity and a capsule, wherein the outer diameter of the capsule is within 80%-99% of the inner diameter of the capsule cavity, and specifically wherein the capsule outer diameter is 5.85 mm and the cavity inner diameter is 6.6 mm (page 18, line 28-page 19, line 3), where 6.6/5.85=1.13, or the receptacle diameter is 13% larger than the capsule diameter.
Given that the claim, as interpreted above, requires the receptacle diameter to be no more than 25% of the capsule diameter, and in Zuber’s example, the receptacle diameter is 13% larger than the capsule diameter, and thus is a specific example within the claimed range, the range is anticipated (see MPEP 2131.03.I).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the capsule receptacle diameter and the capsule diameter of Alston to be 6.6 mm and 5.85 mm respectively, as taught by Zuber, as known and functional dimensions for a capsule receptacle and its associated capsule, where the receptacle is still larger than the capsule as required by Alston’s Figures 2A-B.
Regarding claim 16, Alston in view of Dunne disclose the inhaler article of claim 2, as discussed above.
Examiner notes that claim 16 is rejected and interpreted in light of the rejection under 35 USC 112(b) above.
While Alston illustrates that the capsule receptable diameter is larger than the capsule diameter (see Figs. 2A-B), modified Alston fails to explicitly disclose wherein the capsule receptacle has a diameter that is no more than 25% greater than the capsule diameter.
However, Zuber teaches a capsule cavity and a capsule, wherein the outer diameter of the capsule is within 80%-99% of the inner diameter of the capsule cavity, and specifically wherein the capsule outer diameter is 5.85 mm and the cavity inner diameter is 6.6 mm (page 18, line 28-page 19, line 3), where 6.6/5.85=1.13, or the receptacle diameter is 13% larger than the capsule diameter.
Given that the claim, as interpreted above, requires the receptacle diameter to be no more than 25% of the capsule diameter, and in Zuber’s example, the receptacle diameter is 13% larger than the capsule diameter, and thus is a specific example within the claimed range, the range is anticipated (see MPEP 2131.03.I).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the capsule receptacle diameter and the capsule diameter of Alston to be 6.6 mm and 5.85 mm respectively, as taught by Zuber, as known and functional dimensions for a capsule receptacle and its associated capsule, where the receptacle is still larger than the capsule as required by Alston’s Figures 2A-B.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Alston (US 2004/0206350) in view of Dunne (US 2014/0182587), as applied to claim 1 above, in further view of Stenzler (US 2018/0093050).
Regarding claim 6, Alston in view of Dunne disclose the inhaler article of claim 1, as discussed above.
Modified Alston fails to disclose wherein the inhalable powder comprises nicotine.
However, Stenzler teaches a dry powder inhaler (10) including a capsule (30) (paragraph 27, lines 1-12; Fig. 1), wherein one example of the inhalable powder within the capsule (30) is nicotine (paragraph 11, lines 1-3), and inhalation of nicotine reducing the hazardous effects of smoking (paragraph 2, lines 1-3).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have provided the inhalable powder as nicotine, as taught by Stenzler, as a known compound that can be predictably dispensed from a capsule for inhalation, and reduce the hazardous effects of smoking while still providing the capability of ingesting nicotine.
Claims 7, 11-12, 18, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Alston (US 2004/0206350) in view of Dunne (US 2014/0182587), as applied to claim 1 above, in further view of Buehler (WO 2018/220476).
Regarding claim 7, Alston in view of Dunne disclose the inhaler article of claim 1, as discussed above.
Modified Alston fails to disclose wherein the inhalable powder comprises nicotine particles with a mass median aerodynamic diameter particle size of 0.5-10 micrometers.
However, Buehler teaches an inhaler article (200) including a capsule (201) for dispensing powder comprising nicotine particles, wherein the nicotine particles have a mass median aerodynamic diameter particle size of 1-5 micrometers (Fig. 1; page 18, lines 15-19; claim 9, lines 1-3).
In the case where the range disclosed or taught by the prior art lies within the claimed range, the range is considered prima facie obvious (se MPEP 2144.05.I, and In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990)).
Therefore, it would have been obvious to one of ordinary skill in the art to have provided the inhalable powder as nicotine, as taught by Buehler, as a known compound that can be predictably dispensed from a capsule for inhalation, and to have further provided the MMAD of the nicotine particles in the range of 1-5 micrometers, which lies within the claimed range and is therefore considered prima facie obvious.
Regarding claim 11, Alston in view of Dunne disclose the inhaler article of claim 1, as discussed above.
Modified Alston fails to disclose wherein the body is constructed of cellulosic material.
However, Buehler teaches an inhaler article (200) including a capsule (201) for dispensing powder comprising nicotine particles (page 18, lines 15-19), wherein the body of the device is formed of a cellulosic material which may be biodegradable (page 3, lines 27-30).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the body of the modified Alston inhaler article to be comprised of a cellulosic material, as taught by Buehler, as a known material for fabricating the inhaler article body from that may also be biodegradable.
Regarding claim 12, Alston in view of Dunne disclose the inhaler article of claim 1, as discussed above.
Alston discloses wherein the body (105) comprises a tubular member (see Figs. 2A-B).
Modified Alston fails to disclose wherein the tubular member is constructed of cellulosic material.
However, Buehler teaches an inhaler article (200) including a capsule (201) for dispensing powder comprising nicotine particles (page 18, lines 15-19), wherein the body of the device is formed of a cellulosic material which may be biodegradable (page 3, lines 27-30).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the tubular member of the body of the modified Alston inhaler article to be comprised of a cellulosic material, as taught by Buehler, as a known material for fabricating the inhaler article body from, that may also be biodegradable.
Regarding claim 18, Alston in view of Dunne disclose the inhaler article of claim 1, as discussed above.
Modified Alston fails to disclose wherein the inhalable powder comprises nicotine salt.
However, Buehler teaches an inhaler article (200) including a capsule (201) for dispensing powder comprising nicotine particles (page 18, lines 15-19), wherein nicotine is defined as including nicotine salts (page 3, lines 7-8).
Therefore, it would have been obvious to one of ordinary skill in the art to have provided the inhalable powder as nicotine salts, as taught by Buehler, as a known compound that can be predictably dispensed from a capsule for inhalation.
Regarding claim 20, Alston in view of Dunne disclose the inhaler article of claim 1, as discussed above.
Alston discloses wherein the body (105) comprises a tubular member (see Figs. 2A-B).
Modified Alston fails to disclose wherein the tubular member of the body is constructed of paper.
However, Buehler teaches an inhaler article (200) including a capsule (201) for dispensing powder comprising nicotine particles (page 18, lines 15-19), wherein the body of the device is formed of paper which may be biodegradable (page 3, lines 27-30).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the body of the modified Alston inhaler article to be comprised of paper, as taught by Buehler, as a known material for fabricating the inhaler article body from that may also be biodegradable.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Alston (US 2004/0206350) in view of Dunne (US 2014/0182587), as applied to claim 1 above, in further view of Zuber (US 2018/0369517).
Regarding claim 10, Alston in view of Dunne disclose the inhaler article of claim 1, as discussed above.
Modified Alston fails to disclose wherein the capsule is a size 1 to a size 4 capsule.
However, Zuber teaches an inhale article (1) for the inhalation of nicotine, wherein the capsule is chosen to be a size 3 capsule (paragraph 24, lines 1-14; paragraph 58, lines 1-9; Fig. 1 note MPEP 2131.03, where a specific example from the prior art within the claimed range anticipates the range).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the capsule size of modified Alston to specifically be a size 3 capsule for inhaling nicotine powder, as taught by Zuber, as a known formulation and capsule size for use with an inhaler article.
Claims 14-15 are rejected under 35 U.S.C. 103 as being unpatentable over Alston (US 2004/0206350) in view of Dunne (US 2014/0182587), as applied to claim 1 above, in further view of Buehler (US 2017/0135397).
Regarding claim 14, Alston in view of Dunne disclose the inhaler article of claim 1, as discussed above.
While Alston discloses an opening (145) through which a user can inhale at the downstream end of the body (105) (paragraph 23, lines 9-13; Fig. 1A, note the annotated version above for the downstream end), presently modified Alston fails to disclose a mouthpiece element received at the opening.
However, Buehler teaches an inhaler article (30) to deliver nicotine powder (paragraph 74, lines 1-2; Figs. 1 and 3), wherein the device further includes a detachable mouthpiece element (paragraph 57, lines 11-13).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of modified Alston to further include a detachable mouthpiece element placed at the opening at the downstream end, such a detachable mouthpiece element taught by Buehler, in order to facilitate the removal of the portion placed within the user’s mouth for cleaning.
Regarding claim 15, Alston in view of Dunne and Buehler disclose the inhaler article of claim 14, as discussed above.
Presently modified Alston discloses wherein the mouthpiece element (see paragraph 57 lines 11-13 of Buehler) defines a downstream end of the capsule receptacle (Alston: 110) (note Fig. 1A of Alston, where the opening 145 where the mouthpiece is placed as modified, is downstream of chamber 110).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Clarke (US 5,727,546) is cited for its illustration of apertures in a capsule near a first end as shown in Figure 1A.
Valentini (US 5,152,284) is cited for its capsule holes 42 and 44 near a first end as shown in Figure 1.
Valentini (US 4,069,819) is cited for its capsule holes near a first end as shown in Figure 5.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PAIGE BUGG whose telephone number is (571)272-8053. The examiner can normally be reached Monday-Friday 9-5.
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/PAIGE KATHLEEN BUGG/Primary Examiner, Art Unit 3785