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 .
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1, 3-8, 10, 13-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Soundararajan et al. U.S. Publication 2014/0215790 A1 in view of Perreault U.S. Publication 2005/0229670 A1.
Regarding Claim 1, Soundararajan et al. discloses a loading device 100 for a stent-valve 200 (abstract, paragraph [0031]) comprising: an elongated body 116 having a proximal end region, a distal end region and a lumen extending therein; a collar 114 coupled to the distal end region of the body 116, the collar 114 including first end region, a second end region and a lumen extending therein; a first compression assembly 130 coupled to the collar, wherein the first compression assembly is configured to shift between a first position and a second position (paragraphs [0029-0030]). However, Soundararajan et al. does not expressly disclose wherein a second compression assembly coupled to the collar, wherein the second compression assembly is configured to shift between a third position and a fourth position. Perreault teaches a loading device as seen in Figure 1-10 in the same field of endeavor for delivery of a stent valve (abstract, paragraphs [0033], [0061]), the loading device comprising collar 21 having a first end, second end and a lumen and a first compression assembly 15 coupled to the collar 21 (see Figure 1-9 and paragraph [0053-0055]) and a second compression assembly 15a coupled to the collar 21, wherein the first compression assembly 15a is configured to shift between a first and a second position and a second compression assembly 15b that is configured to shift between a third and fourth position (the crimping sections 20 include multiple sections that are independently adjustable or used simultaneously, see abstract and paragraphs [0011-0015], [0019], [0021], [0029-0030]) for the purpose of allowing discrete sections of the medical device to be crimped to the same or different diameters at the same or different times (paragraphs [0011], [0013], [0019], [0021], [0030]). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the first and second compression assembly of Soundararajan et al. to be independently actuated for the purpose of allowing discrete sections of the medical device to be crimped to the same or different diameters at the same or different times (paragraphs [0011], [0013], [0019], [0021], [0030]).
Regarding Claim 3, Soundararajan et al. discloses wherein the first compression assembly is configured to maintain the stent-valve in a radially compressed state when in the first position (paragraph [0030-0031]). Soundararajan does not expressly disclose wherein the second compression assembly is configured to release the stent-valve from the radially compressed state. Perreault teaches a loading device as seen in Figure 1-10 in the same field of endeavor for delivery of a stent valve (abstract, paragraphs [0033], [0061]), the loading device comprising collar 21 having a first end, second end and a lumen and a first compression assembly 15 coupled to the collar 21 (see Figure 1-9 and paragraph [0053-0055]) and a second compression assembly 15a coupled to the collar 21, wherein the first compression assembly 15a is configured to shift between a first and a second position and a second compression assembly 15b that is configured to shift between a third and fourth position (the crimping sections 20 include multiple sections that are independently adjustable or used simultaneously, see abstract and paragraphs [0011-0015], [0019], [0021], [0029-0030]) for the purpose of allowing discrete sections of the medical device to be crimped to the same or different diameters at the same or different times (paragraphs [0011], [0013], [0019], [0021], [0030]). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the first and second compression assembly of Soundararajan et al. to be independently actuated for the purpose of allowing discrete sections of the medical device to be crimped to the same or different diameters at the same or different times (paragraphs [0011], [0013], [0019], [0021], [0030]).
Regarding Claim 4, Soundararajan et al. discloses wherein shifting first compression assembly from the first position to the second position includes releasing the stent-valve from the radially compressed state (Soundararajan discloses the compression assembly forms a cavity 190, wherein the size of the cavity that houses the stent frame can be changed due to the ability of the compression assembly elements 136 to slide with the groove 148 of an adjacent compression element, thus the cavity 190 can change from a first diameter to a second diameter, see paragraph [0030]).
Regarding Claim 5, Soundararajan et al. does not expressly disclose wherein the first compression assembly is configured to release the stent-valve from the radially compressed state while the second compression assembly maintains the stent-valve in radially compressed state. Perreault teaches a loading device as seen in Figure 1-10 in the same field of endeavor for delivery of a stent valve (abstract, paragraphs [0033], [0061]), the loading device comprising collar 21 having a first end, second end and a lumen and a first compression assembly 15 coupled to the collar 21 (see Figure 1-9 and paragraph [0053-0055]) and a second compression assembly 15a coupled to the collar 21, wherein the first compression assembly 15a is configured to shift between a first and a second position and a second compression assembly 15b that is configured to shift between a third and fourth position (the crimping sections 20 include multiple sections that are independently adjustable or used simultaneously, see abstract and paragraphs [0011-0015], [0019], [0021], [0029-0030]) for the purpose of allowing discrete sections of the medical device to be crimped to the same or different diameters at the same or different times (paragraphs [0011], [0013], [0019], [0021], [0030]). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the first and second compression assembly of Soundararajan et al. to be independently actuated for the purpose of allowing discrete sections of the medical device to be crimped to the same or different diameters at the same or different times (paragraphs [0011], [0013], [0019], [0021], [0030]).
Regarding Claim 6, Soundararajan does not expressly disclose wherein the second compression assembly is configured to release the stent-valve from the radially compressed state after the first compression assembly releases the stent-valve from the radially compressed state. Perreault teaches a loading device as seen in Figure 1-10 in the same field of endeavor for delivery of a stent valve (abstract, paragraphs [0033], [0061]), the loading device comprising collar 21 having a first end, second end and a lumen and a first compression assembly 15 coupled to the collar 21 (see Figure 1-9 and paragraph [0053-0055]) and a second compression assembly 15a coupled to the collar 21, wherein the first compression assembly 15a is configured to shift between a first and a second position and a second compression assembly 15b that is configured to shift between a third and fourth position (the crimping sections 20 include multiple sections that are independently adjustable or used simultaneously, see abstract and paragraphs [0011-0015], [0019], [0021], [0029-0030]) for the purpose of allowing discrete sections of the medical device to be crimped to the same or different diameters at the same or different times (paragraphs [0011], [0013], [0019], [0021], [0030]) and reduce the size of the stent (paragraphs [0069-0070], [0072], [0075]). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the first and second compression assembly of Soundararajan et al. to be independently actuated for the purpose of allowing discrete sections of the medical device to be crimped to the same or different diameters at the same or different times (paragraphs [0011], [0013], [0019], [0021], [0030]).
Regarding Claim 7, Soundararajan et al. discloses wherein the first compression assembly 130 includes a first compression member (a plurality of blades is shown in Figure 8 forming an annular ring) coupled to a first actuation member 110 (abstract and paragraphs [0022], [0029], [0032-034]).
Regarding Claim 8, Soundararajan et al. discloses wherein actuation of the first actuation member 110 shifts the first compression member between the first position and the second position (paragraphs [0022], [0032-0035]).
Regarding Claim 10, Soundararajan et al. does not expressly disclose wherein the first actuation member includes a cam. Perreault teaches a loading device as seen in Figure 1-10 in the same field of endeavor for delivery of a stent valve (abstract, paragraphs [0033], [0061]), the loading device comprising collar 21 having a first end, second end and a lumen and a first compression assembly 15 coupled to the collar 21 and coupled to a first actuator (see Figure 1-9 and paragraph [0053-0055] and [0069-0070]), wherein the actuation device can be motors, gear systems, frictional methods such as tabs for manual actuation (paragraph [0070]), including a cam 40 (see Figures 1, 9-12 and paragraphs [0023], [0053], [0069-0070], [0072] and [0074]) for the purpose of allowing discrete sections of the medical device to be crimped to the same or different diameters at the same or different times (paragraphs [0011], [0013], [0019], [0021], [0030]) and reduce the size of the stent (paragraphs [0069-0070], [0072], [0075]). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the first actuation member to be a cam as taught by Perreault et al. for the purpose of allowing discrete sections of the medical device to be crimped to the same or different diameters at the same or different times and reduce the size of the stent.
Regarding Claim 13, Soundararajan et al. discloses wherein the first compression member includes a compression ring (the plurality of blades forming the compression assembly is formed into an annular shape), and wherein the circumference of the compression ring is circumferentially discontinuous (as seen in Figure 1, the blades are not continuous and forms a plurality of ridges).
Regarding Claim 14, Soundararajan et al. discloses wherein the compression ring includes an aperture 190 having a first diameter when the first compression assembly is in the first position (as seen in Figures 10 and 12 and paragraph [00030], [0033]), and wherein the aperture has a second diameter when the first compression assembly is in the second position, and wherein the first diameter is less than the second diameter (paragraphs [0034-0035]).
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Soundararajan et al. U.S. Publication 2014/0215790 A1 in view of Perreault U.S. Publication 2005/0229670 A1 and further in view of Serrano et al. U.S. Publication 2010/0274342 A1.
Regarding Claim 9, Soundararajan et al. in view of Perreault discloses a first compression assembly includes a first compression member coupled to a first actuation member and a second compression member coupled to a second actuation member (see Perreault, paragraphs [0017], [0019-0020], [0022], [0029], [0031], [0033], [0069-0070]), the first and second crimping sections 20 are independently adjustable or used simultaneously, see abstract and paragraphs [0011-0015], [0019], [0021], [0029-0030]) for the purpose of allowing discrete sections of the medical device to be crimped to the same or different diameters at the same or different times (paragraphs [0011], [0013], [0019], [0021], [0030]) and reduce the size of the stent. However, Soundararajan et al. does not expressly disclose a second compression member coupled to a second actuation member, and wherein both the first actuation member and the second actuation member include a threaded pin. Serrano et al. teaches a loading device 10 as seen in Figure 1-11 in the same field of endeavor for delivery of a stent valve (abstract, paragraphs [0007], [0012-0013], [0040-0041]), the loading device comprises a first compression assembly 12 coupled to a first actuator 20 (see Figure 1-and paragraph [0053-0055] and [0069-0070]) and a second compression assembly 12 coupled to a second actuation member 20, wherein the first and second compression assembly is longitudinally offset from each other (paragraphs [0017], [0019-0020], [0022], [0029], [0031], [0033], [0069-0070]), wherein the first actuation member 20 includes a threaded pin 28 and a second actuation member 20 includes a threaded pin 28 (as seen in Figures 4-6 and paragraphs [0014], [0016-0017], [0042-0043], [0045-0046]) for the purpose of moving the first and second compression member from an open configuration to an closed configuration to reduce the diameter of the stent to a crimped diameter (paragraph [0042-0043]). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Soundararajan’s first actuation member coupled to a first actuation member to further include a second actuation member coupled to a second actuation member, wherein the first and second actuation member includes a threaded pin as taught by Serrano et al. for the purpose of moving the first and second compression member from an open configuration to an closed configuration to reduce the diameter of the stent to a crimped diameter.
Claim(s) 11-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Soundararajan et al. U.S. Publication 2014/0215790 A1 in view of Perreault U.S. Publication 2005/0229670 A1 and further in view of Goff et al. U.S. Publication 2017/0087620 A1.
Regarding Claims 11, 12, Soundararajan et al. in view of Perreault discloses a first compression assembly includes a first compression member coupled to a first actuation member (see rejections above). However, Soundararajan et al. does not expressly disclose wherein the first actuation member includes compression lever, wherein the compression lever includes a first projection and a second projection, and wherein the first projection is configured to releasably engage with the second projection. Goff et al. teaches a loading device as seen in Figures 5-6 in the same field of endeavor for delivery of a stent valve (abstract, paragraphs [0006], [0035]), the loading device comprising first compression assembly 14 coupled to a first actuator 26 (as seen in Figure 5, paragraph [0035]) wherein the first actuation member includes a compression lever 52 (see Figures 4-5 and paragraph [0035-0036]), the compression lever includes a first projection (the inclined tip) that engages with a second projection 50 (paragraph [0035]) for the purpose of moving the first compression assembly from an open and closed position and continuously increase or decrease the diameter of the central cavity which houses the stent and allow the stent to be compressed (paragraph [0035]). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Soundararajan’s first actuation member to include a compression lever, wherein the compression lever includes a first and second projection, the first projection is configured to releasably engage with the second projection for the purpose of moving the first compression assembly from an open and closed position and continuously increase or decrease the diameter of the central cavity which houses the stent and allow the stent to be compressed.
Claim(s) 15-16 and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Soundararajan et al. U.S. Publication 2014/0215790 A1 in view of Straubinger et al. U.S. Publication 2010/0292779 A1 and further in view of Edin U.S. Publication 2005/0234537 A1.
Regarding Claim 15, Soundararajan et al. discloses a loading device 100 for a stent-valve 200 (abstract, paragraph [0031]) comprising: an elongated body 116 having a proximal end region, a distal end region and a lumen extending therein; a collar 114 coupled to the distal end region of the body 116, the collar 114 including first end region, a second end region and a lumen extending therein; a first compression assembly 130 coupled to the collar, wherein the first compression assembly is configured to shift between a first position and a second position (paragraphs [0029-0030]). Soundararajan et al. discloses the central cavity 122 is sized and shaped to receive the stent (paragraph [0022] and claim 2). However, Soundararajan et al. does not expressly disclose the lumen is conical. Straubinger et al. teaches a loading device 1 in the same filed of endeavor for compressing stent-valve (abstract), the loading device comprising an elongated body 10, 21 having a proximal end, distal end, and a conical lumen (see Figure 9a-9b, 10c-11c) to accommodate the conical shape of the prosthesis (paragraph [0173], see Figure 11c). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Soundararajan’s elongated body to have a conical lumen extending therein as taught by Straubinger et al. for the purpose of accommodating the conical shape of the stent valve. However, Soundararajan et al. does not expressly disclose a second compression assembly coupled to the collar, wherein the first compression assembly is longitudinally offset from the second compression assembly; wherein the first compression assembly and the second compression assembly are configured to maintain the stent-valve in a radially compressed state while in a first position; wherein the first compression assembly is configured to release the stent-valve from the radially compressed state while the second compression assembly maintains the stent-valve in the radially compressed state. Edin teaches a loading device 10 as seen in Figure 13 in the same field of endeavor for delivery of a stent valve (abstract, paragraphs [0007], [0012-0013], [0040-0041]), the loading device comprises a first compression assembly 26a coupled to a first actuator 74a (see Figure 13 and paragraph [0075-0076]) and a second compression assembly 26b coupled to a second actuation member 74b, wherein the first and second compression assembly is longitudinally offset from each other (as seen in Figure 13) for the purpose of moving the first and second compression member independently from each other from an open configuration to an closed configuration to reduce the diameter of the stent to a crimped diameter (paragraph [0075-0077] and [0081-0083]). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Soundararajan’s first actuation member coupled to a first actuation member to further include a second actuation member coupled to a second actuation member, wherein the first and second actuation member is longitudinally offset as taught by Serrano et al. for the purpose of moving the first and second compression member independently from each other from an open configuration to an closed configuration to reduce the diameter of the stent to a crimped diameter.
Regarding Claim 16, Soundararajan et al. discloses wherein the first compression assembly 130 includes a first compression member (a plurality of blades is shown in Figure 8 forming an annular ring) coupled to a first actuation member 110 (abstract and paragraphs [0022], [0029], [0032-034]).
Regarding Claim 19, Soundararajan et al. discloses wherein the first compression member includes a compression ring (the plurality of blades forming the compression assembly is formed into an annular shape), and wherein the circumference of the compression ring is circumferentially discontinuous (as seen in Figure 1, the blades are not continuous and forms a plurality of ridges).
Claim(s) 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Soundararajan et al. U.S. Publication 2014/0215790 A1 in view of Straubinger et al. U.S. Publication 2010/0292779 A1 and in view of Edin U.S. Publication 2005/0234537 A1 and further in view of Perreault U.S. Publication 2005/0229670 A1.
Regarding Claim 17, Soundararajan et al. does not expressly disclose wherein the first actuation member includes a cam. Perreault teaches a loading device as seen in Figure 1-10 in the same field of endeavor for delivery of a stent valve (abstract, paragraphs [0033], [0061]), the loading device comprising collar 21 having a first end, second end and a lumen and a first compression assembly 15 coupled to the collar 21 and coupled to a first actuator (see Figure 1-9 and paragraph [0053-0055] and [0069-0070]), wherein the actuation device can be motors, gear systems, frictional methods such as tabs for manual actuation (paragraph [0070]), including a cam 40 (see Figures 1, 9-12 and paragraphs [0023], [0053], [0069-0070], [0072] and [0074]) for the purpose of allowing discrete sections of the medical device to be crimped to the same or different diameters at the same or different times (paragraphs [0011], [0013], [0019], [0021], [0030]) and reduce the size of the stent (paragraphs [0069-0070], [0072], [0075]). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the first actuation member to be a cam as taught by Perreault et al. for the purpose of allowing discrete sections of the medical device to be crimped to the same or different diameters at the same or different times and reduce the size of the stent.
Claim(s) 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over as being unpatentable over Soundararajan et al. U.S. Publication 2014/0215790 A1 in view of Straubinger et al. U.S. Publication 2010/0292779 A1 and in view of Edin U.S. Publication 2005/0234537 A1 and further in view of Goff et al. U.S. Publication 2017/0087620 A1.
Regarding Claim 18, Soundararajan et al. in view of Perreault discloses a first compression assembly includes a first compression member coupled to a first actuation member (see rejections above). However, Soundararajan et al. does not expressly disclose wherein the first actuation member includes compression lever. Goff et al. teaches a loading device as seen in Figures 5-6 in the same field of endeavor for delivery of a stent valve (abstract, paragraphs [0006], [0035]), the loading device comprising first compression assembly 14 coupled to a first actuator 26 (as seen in Figure 5, paragraph [0035]) wherein the first actuation member includes a compression lever 52 (see Figures 4-5 and paragraph [0035-0036]) for the purpose of moving the first compression assembly from an open and closed position and continuously increase or decrease the diameter of the central cavity which houses the stent and allow the stent to be compressed (paragraph [0035]). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Soundararajan’s first actuation member to include a compression lever for the purpose of moving the first compression assembly from an open and closed position and continuously increase or decrease the diameter of the central cavity which houses the stent and allow the stent to be compressed.
Claim(s) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over as being unpatentable over Soundararajan et al. U.S. Publication 2014/0215790 A1 in view of Maimon et al. U.S. Publication 2013/0152659 A1 and further in view of Perreault U.S. Publication 2005/0229670 A1
Regarding Claim 20, Soundararajan et al. discloses a method of loading a stent-valve 200 on to a stent-valve delivery device 100 (paragraphs [0002], [0004], [0020]), the method comprising: the stent-valve loading device including: an elongated body 116; a collar 114 coupled to the distal end region of the body; a first compression assembly 130 coupled to the collar 114, the first compression assembly including a first compression region (a plurality of blades 132). However, Soundararajan et al. does not expressly disclose positioning a first sheath of the stent-valve delivery device adjacent to a stent- valve loading device and advancing the first sheath of the stent-valve delivery device over a first portion of the stent-valve; and advancing the first sheath of the stent-valve delivery device over a second portion of the stent-valve. Maimon et al. teaches a method for loading a prosthetic heart valve 12 (as seen in Figure 5 and paragraph [0007]), the method comprising a stent-valve loading device 10 (as seen in Figure 5) having an elongated body 80 and a collar 40 coupled to a distal end of the elongated body 80 and a first compression assembly 20. Maimon et al. further teaches using an introducer sheath in combination with the compression assembly to allow the valve to be retracted proximally out of the compression assembly 200 and advanced through the compression assembly and through an introducer sheath which is already inserted into a patient (paragraph [0038-0039]). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the method of loading of Soundararajan et al. to further include an introducer sheath that is used to introduce the expanded stent that was released from the compression assembly. However, Soundararajan et al. does not expressly disclose a second compression assembly coupled to the collar, the second compression assembly including a second compression region; and compressing the stent-valve within the first compression region and the second compression region, releasing the stent from the first compression region. Perreault teaches a loading device as seen in Figure 1-10 in the same field of endeavor for delivery of a stent valve (abstract, paragraphs [0033], [0061]), the loading device comprising collar 21 having a first end, second end and a lumen and a first compression assembly 15 coupled to the collar 21 (see Figure 1-9 and paragraph [0053-0055]) and a second compression assembly 15a coupled to the collar 21, wherein the first compression assembly 15a is configured to shift between a first and a second position and a second compression assembly 15b that is configured to shift between a third and fourth position (the crimping sections 20 include multiple sections that are independently adjustable or used simultaneously, see abstract and paragraphs [0011-0015], [0019], [0021], [0029-0030]) for the purpose of allowing discrete sections of the medical device to be crimped to the same or different diameters at the same or different times (paragraphs [0011], [0013], [0019], [0021], [0030]) and reduce the size of the stent (paragraphs [0069-0070], [0072], [0075]). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the compression assembly of Soundararajan et al. to further include a first and second compression assembly as taught by Perreault for the purpose of allowing discrete sections of the medical device to be crimped to the same or different diameters at the same or different times (paragraphs [0011], [0013], [0019], [0021], [0030]).
Conclusion
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/SEEMA MATHEW/
Primary Examiner, Art Unit 3774