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 .
Information Disclosure Statement
The information disclosure statement (IDS), submitted on 9 September 2025, has been considered by the examiner.
Response to Amendment
This office action is responsive to the amendment filed on 22 August 2025. As directed by the amendment: claims 1, 67, and 121 have been amended, claims 2-3, 5-10,12-39, 41-58, 60, 62, 64-66, 68-72, 74-79, 81-105, 108-114, 116-118, and 120 have been or remain canceled. Thus claims 1, 4, 11, 40, 59, 61, 63, 67, 73, 80, 106-107, 115, 119, and 121-126 are presently pending in this application, and claims 67, 73, 80, 106-107, 115, and 119 remain withdrawn.
Response to Arguments
Applicant's arguments filed 22 August 2025 have been fully considered but they are not persuasive.
Applicant argues the cited references fail to teach the amended range of the length of extension of the fluid delivery members beyond the distal end of the elongate member in the extended configuration. The examiner agrees that this range is not disclosed, however, it would be obvious to modify the prior art to be in the range as claimed, as outlined further below, this is a result effective variable and it would be routine optimization to arrive at the claimed invention.
Applicant further argues it would not be obvious to modify McGuckin ‘238 in view of McGuckin ‘683 because McGuckin ‘683 teaches away from the claimed configuration and is an improvement upon McGuckin ‘238 for injection of ablation fluid inside the lesion. The examiner respectfully disagrees. While McGuckin ‘683 does teach the configuration with the tines not extending beyond the distal tip, this does not teach away from the use of the configuration in the primary reference McGuckin ‘238. McGuckin ‘683 is not relied upon to teach the position of the tines relative to the distal tip, it is relied upon to teach the outer diameter of the elongate member. Further McGuckin ‘683 describes the configuration as preferred because it better controls the zone of tissue ablation. A preferred embodiment does not teach away from other embodiments. "A known or obvious composition does not become patentable simply because it has been described as somewhat inferior to some other product for the same use." In re Gurley, 27 F.3d 551, 554, 31 USPQ2d 1130, 1132 (Fed. Cir. 1994). Applicant argues modification of McGuckin ‘683 would render it inoperable for its intended purpose of improved controlled injection of ablation fluid. The examiner notes McGuckin ‘683 is not being modified, instead McGuckin ‘238 is being modified in a way that would not change its intended purpose.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 4, 11, and 40 are rejected under 35 U.S.C. 103 as being unpatentable over McGuckin Jr. et al. (US 2002/0120238 A1), hereinafter McGuckin ‘238, in view of McGuckin Jr. et al. (US 2004/0204683 A1), hereinafter McGuckin ‘683.
Regarding claim 1, McGuckin ‘238 discloses a fluid injection device (10 Fig 1) comprising: an elongate member (20 Fig 1) having a proximal end (23 Fig 6) and a distal end (30 Fig 6) and comprising an inner wall defining a lumen therein (See the lumen and the wall of needle 20 in Fig 11); a plurality of fluid delivery members (24a-c Fig 3) disposed within the lumen of the elongate member (As shown in Fig 11) and having a retracted configuration ([0051] “FIG. 1 illustrates the tines in the retracted or non-deployed position with the actuator 18 in its initial (neutral) position.”) and an extended configuration ([0052] “FIGS. 4 and 5 illustrate the tines 24a-24d in a second or fully deployed position.”), wherein the plurality of fluid delivery members are configured to extend out of the distal end of the elongate member in the extended configuration ([0052] “This deploys the tines 24a-24d further from the distal end 30 of the needle 20”), wherein each of the plurality of fluid delivery members extend distally beyond the distal end of the elongate member in the extended configuration (See the extension of the tines beyond distal end 30 in Fig 4), wherein each of the plurality of fluid delivery members comprises an outlet port (26 Fig 4) at a distal end of the respective fluid delivery member (the openings 26 are located at the distal ends of the tines as shown in Fig 4), and an inner wall defining a fluid delivery lumen therein, the fluid delivery lumen being fluidically coupled to the outlet port ([0017] “a plurality of tines positioned in the elongated member, each having a lumen and at least one opening communicating with the lumen for delivering fluid to the lesion”), wherein each of the fluid delivery lumens is fluidically independent of every other fluid delivery lumen of the plurality of fluid delivery members (because of the inner wall defining the lumen of each of the fluid delivery members, fluid in one lumen would not mix with fluid in another lumen, as such, they are fluidically independent); and a fluid delivery mechanism ([0066] “three way stopcock”) operably coupled to the plurality of fluid delivery members, wherein actuation of the fluid delivery mechanism (positioning the stopcock and inserting the fluid through stopcock to provide fluid flow as described in [0066] is the actuation of the stopcock) causes fluid to pass through the outlet ports from the respective fluid delivery members of the plurality of fluid delivery members ([0051] “Each of the tines 24a, 24b, 24c and 24d has a respective penetrating tip 25a-25d and a series of openings 26 for delivering fluid, e.g. ethanol or acetic acid, to the tissue.”, [0066] “cold saline is injected through the tines 24a-24d in their retracted position within needle 20”).
However, McGuckin ‘238 fails to disclose the elongate member having an outer diameter of about 0.9 mm to about 3.5 mm and wherein each of the plurality of fluid delivery members extend distally beyond the distal end of the elongate member in the extended configuration in a range of 5 mm to 40 mm.
McGuckin ‘683 teaches the elongate member having an outer diameter of about 0.9 mm to about 3.5 mm ([0082] “The needle 50 outer diameter is about 0.070 inches” 0.070 inches is 1.778mm). It would have been obvious to one of ordinary skill in the art at the time of effective filing for the elongate member of McGuckin ‘238 to include the outer diameter as taught by McGuckin ‘683 for “minimizing the apparatus size, while maintaining adequate fluid supply and structural integrity” [0082].
McGuckin ‘238 discloses the tines extend a distance beyond the distal end of the elongate member in the extended configuration. However, McGuckin ‘238 does not expressly disclose each of the plurality of fluid delivery members extend distally beyond the distal end of the elongate member in the extended configuration in a range of 5 mm to 40 mm as required by the claim.
McGuckin ‘238 discloses [0052] the distance that each of the plurality of fluid delivery members extends distally beyond the distal end of the elongate member in the extended configuration is a variable that when it is changed results in a different sized tissue treatment zone ([0052] “This deploys the tines 24a-24d further from the distal end 30 of the needle 20, and at a greater angle to the longitudinal axis "a" of the needle 20, providing a larger tissue treatment zone as will be described in detail below.” Tine 24d moves distally, and tines 24a-24c move distally as well as away from the longitudinal axis “a” between the first and second deployed positions as shown between Figs 3 and 5) Further, it appears that one of ordinary skill in the art would have had a reasonable expectation of success in modifying the McGuckin ‘238 device to have each of the plurality of fluid delivery members extending distally beyond the distal end of the elongate member in the extended configuration within the claimed range, as it involves only adjusting the dimensions of components disclosed to require adjustment. Therefore, it would have been obvious to one having ordinary skill in the art at the time of the invention to modify the device of modified McGuckin ‘238 by making the distance be between 5 mm and 40 mm as a matter of routine optimization since it has been held that “where 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).
Regarding claim 4, modified McGuckin ‘238 teaches the device of claim 1. McGuckin ‘238 further teaches wherein the plurality of fluid delivery members are configured to retract from the extended configuration to the retracted configuration simultaneously with fluid delivery from the fluid delivery members (As fluid delivery is unrelated to the positioning of the fluid delivery members, fluid could be delivered while the delivery members are in any position or while moving, including delivery simultaneously with retraction from the extended position).
Regarding claim 11, modified McGuckin ‘238 discloses the device of claim 1. However, modified McGuckin ‘238 is silent to wherein the elongate member has a length in a range of about 4 cm to about 20 cm.
There is no evidence of record that establishes that changing the length of the elongate member would result in a difference in function of the modified McGuckin ‘238 device. Further, a person having ordinary skill in the art, being faced with modifying the needle of modified McGuckin ‘238, would have a reasonable expectation of success in making such a modification and it appears the device would function as intended being given the claimed lengths. Lastly, applicant has not disclosed that the claimed range solves any stated problem, indicating that the length is within the claimed range “in some embodiments”, and offering other acceptable ranges (e.g about 100 cm to about 250 cm, specification at para. [0010]) and therefore there appears to be no criticality placed on the range as claimed such that it produces an unexpected result.
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 length of the elongate member of modified McGuckin ‘238 to have a range of about 4cm to about 20cm as an obvious matter of design choice within the skill of the art.
Regarding claim 40, modified McGuckin ‘238 teaches the device of claim 1. Modified McGuckin ‘238 further teaches further comprising an actuator (18 Fig 1) coupled to the proximal end of the elongate member (the plunger 18 is coupled to the proximal end of the needle 20 through the tubing 70 as shown in Fig 12, fluid would flow from the plunger to the proximal end of the needle, the plunger is also retained in place relative to the needle by the housing 12)and operably coupled to the fluid delivery mechanism (upon operation of the stopcock, fluid would either flow through the plunger 18 into tubing 70 or not flow), wherein engaging the actuator moves the plurality of fluid delivery members from the retracted configuration to the extended configuration ([0054] “rotation and axial movement (advancement/retraction) of plunger 18 rotates and moves the mounting tube 70 axially, which in turn rotates and moves the connected tines 24a-24d axially”) and wherein disengaging the actuator moves the plurality of fluid delivery members from the extended configuration to the retracted configuration (withdrawal of the plunger withdraws the tines, [0048] “the interaction of the release lever and finger to release the plunger to enable withdrawal of the tines, mounting tube and plunger from the needle and housing”).
Claim 59 is rejected under 35 U.S.C. 103 as being unpatentable over McGuckin ‘238, in view of McGuckin ‘683, and Thompson et al. (US 2005/0137575 A1).
Regarding claim 59, modified McGuckin ‘238 teaches the device of claim 1. McGuckin ‘238 further discloses one or more fluid sources ([0066] “saline” “acetic acid”) fluidically coupled to one or more of the fluid delivery lumens or one or more of a plurality of fluid delivery channels ([0054] “This enables ethanol (or other ablation fluid) to flow around the mounting pin 72 and through the tines 24a-24d for delivery to the patient.”).
However, modified McGuckin ‘238 is silent to the fluid sources are cartridges.
Thompson et al. teaches a fluid source is a cartridge ([0005] “a cartridge containing a therapeutic agent to be injected into the tissue site”). It would have been obvious to one of ordinary skill in the art at the time of effective filing for the fluid source in the device of modified McGuckin ‘238 to be a cartridge to provide a therapeutic fluid in a predetermined volume [0005].
Claims 61 and 63 are rejected under 35 U.S.C. 103 as being unpatentable over McGuckin ‘238, in view of McGuckin ‘683, and De Haas (US 2016/0193365 A1).
Regarding claim 61, modified McGuckin ‘238 discloses the device of claim 1. However, modified McGuckin ‘238 is silent to further comprising a population of fluorescent tracking microspheres (FTM).
De Haas teaches a population of fluorescent tracking microspheres (FTM) ([0004] “fluorescent dye encapsulated by polymeric microspheres”).
It would have been obvious to one of ordinary skill in the art at the time of effective filing for the device of modified McGuckin ‘238 to include a population of FTM as taught by de Haas to provide material for “marking tissue (e.g., healthy tissue or lesions) or lymph nodes of interest that is stable, exhibits minimal degradation, and does not migrate once it is introduced to the tissue or lymph node of interest.” [0003]
Regarding claim 63, modified McGuckin ‘238 teaches the device of claim 61. Modified McGuckin ‘238 further teaches wherein the fluorescent tracking microspheres comprise polystyrene (de Haas- [0008] “the polymeric microspheres can include […] polystyrene”).
Claims 121-124 are rejected under 35 U.S.C. 103 as being unpatentable over McGuckin ‘238, in view of Baudino (US 6,353,762 B1).
Regarding claim 121, McGuckin ‘238 discloses a fluid injection device (10 Fig 1) comprising: an elongate member (20 Fig 1) having a proximal end (23 Fig 6) and a distal end (30 Fig 6) and comprising an inner wall defining a lumen therein (See the lumen and the wall of needle 20 in Fig 11); a plurality of fluid delivery members (24a-c Fig 3) disposed within the lumen of the elongate member (As shown in Fig 11) and having a retracted configuration ([0051] “FIG. 1 illustrates the tines in the retracted or non-deployed position with the actuator 18 in its initial (neutral) position.”) and an extended configuration ([0052] “FIGS. 4 and 5 illustrate the tines 24a-24d in a second or fully deployed position.”), wherein the plurality of fluid delivery members are configured to extend out of the distal end of the elongate member in the extended configuration ([0052] “This deploys the tines 24a-24d further from the distal end 30 of the needle 20”), wherein each of the plurality of fluid delivery members extend distally beyond the distal end of the elongate member in the extended configuration (See the extension of the tines beyond distal end 30 in Fig 4), wherein each of the plurality of fluid delivery members comprises an outlet port (26 Fig 4) at a distal end of the respective fluid delivery member (the openings 26 are located at the distal ends of the tines as shown in Fig 4), and an inner wall defining a fluid delivery lumen therein, the fluid delivery lumen being fluidically coupled to the outlet port ([0017] “a plurality of tines positioned in the elongated member, each having a lumen and at least one opening communicating with the lumen for delivering fluid to the lesion”), wherein each of the fluid delivery lumens is fluidically independent of every other fluid delivery lumen of the plurality of fluid delivery members (because of the inner wall defining the lumen of each of the fluid delivery members, fluid in one lumen would not mix with fluid in another lumen, as such, they are fluidically independent); and a fluid delivery mechanism ([0066] “three way stopcock”) operably coupled to the plurality of fluid delivery members, wherein actuation of the fluid delivery mechanism (positioning the stopcock and inserting the fluid through stopcock to provide fluid flow as described in [0066] is the actuation of the stopcock) causes fluid to pass through the outlet ports from the respective fluid delivery members of the plurality of fluid delivery members ([0051] “Each of the tines 24a, 24b, 24c and 24d has a respective penetrating tip 25a-25d and a series of openings 26 for delivering fluid, e.g. ethanol or acetic acid, to the tissue.”, [0066] “cold saline is injected through the tines 24a-24d in their retracted position within needle 20”).
However, McGuckin ‘238 fails to disclose wherein each of the plurality of fluid delivery members extend distally beyond the distal end of the elongate member in the extended configuration in a range of 5 mm to 40 mm and wherein the distal end of the elongate member comprises angling elements configured to angle the distal end of each of the plurality of fluid delivery members away from a longitudinal axis of the elongate member in the extended configuration.
Baudino teaches a distal end of an elongate member (905 Fig 9A) comprises angling elements (openings 915 Fig 9A) configured to angle the distal end of each of the plurality of members (910 Fig 9A) away from a longitudinal axis of the elongate member in the extended configuration (See the angle in Fig 9A). It would have been obvious to one of ordinary skill in the art at the time of effective filing for the distal end of the elongate member of McGuckin ‘238 to comprise the angling elements with the limitations as taught by Baudino to direct the fluid delivery members along a predetermined angle and trajectory to achieve a desired geometric configuration of the fluid delivery members (Col 6 lines 13-26).
McGuckin ‘238 discloses the tines extend a distance beyond the distal end of the elongate member in the extended configuration. However, McGuckin ‘238 does not expressly disclose each of the plurality of fluid delivery members extend distally beyond the distal end of the elongate member in the extended configuration in a range of 5 mm to 40 mm as required by the claim.
McGuckin ‘238 discloses [0052] the distance that each of the plurality of fluid delivery members extends distally beyond the distal end of the elongate member in the extended configuration is a variable that when it is changed results in a different sized tissue treatment zone ([0052] “This deploys the tines 24a-24d further from the distal end 30 of the needle 20, and at a greater angle to the longitudinal axis "a" of the needle 20, providing a larger tissue treatment zone as will be described in detail below.” Tine 24d moves distally, and tines 24a-24c move distally as well as away from the longitudinal axis “a” between the first and second deployed positions as shown between Figs 3 and 5.) Further, it appears that one of ordinary skill in the art would have had a reasonable expectation of success in modifying the McGuckin ‘238 device to have each of the plurality of fluid delivery members extending distally beyond the distal end of the elongate member in the extended configuration within the claimed range, as it involves only adjusting the dimensions of components disclosed to require adjustment. Therefore, it would have been obvious to one having ordinary skill in the art at the time of the invention to modify the device of modified McGuckin ‘238 by making the distance be between 5 mm and 40 mm as a matter of routine optimization since it has been held that “where 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).
Regarding claim 122, modified McGuckin ‘238 teaches the device of claim 121. Modified McGuckin ‘238 further teaches wherein each fluid delivery member of the plurality of fluid delivery members comprises a flexible material ([0066] “Nitinol, a nickel titanium alloy, which characteristically exhibits rigidity in the austenitic state and more flexibility in the martensitic state”).
Regarding claim 123, modified McGuckin ‘238 teaches the device of claim 121. Modified McGuckin ‘238 further discloses wherein, in the extended configuration, each of the plurality of fluid delivery members angle away from a longitudinal axis of the elongate member (tines 24a-c angle away from the longitudinal axis “a” as shown in Fig 4, [0069] “the tines 24a-24c extend at a greater angle with respect to the longitudinal axis of the needle 20”).
However, McGuckin ‘238 is silent to a distance between distal ends of each of the plurality of fluid delivery members is in a range of about 1 mm to about 10 mm.
There is no evidence of record that establishes that changing the distance between distal ends of each of the plurality of fluid delivery members in the extended configuration would result in a difference in function of the McGuckin ‘238 device, rather McGuckin ‘238 teaches multiple extended configurations to allow different sized treatment zones. Further, a person having ordinary skill in the art, being faced with modifying the needle of McGuckin ‘238, would have a reasonable expectation of success in making such a modification and it appears the device would function as intended being given the claimed distance. Lastly, applicant has not disclosed that the claimed range solves any stated problem, indicating that the distance “may” be in the claimed range [0140], and offering other acceptable ranges (e.g “a range bounded by any two of the following values: 1 mm, 2 mm, 3 mm, 4, mm, 5 mm, 6 mm, 7 mm, 8 mm, 9 mm, or 10 mm.” specification at para. [0140]) and therefore there appears to be no criticality placed on the range as claimed such that it produces an unexpected result. 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 distance between distal ends of each of the plurality of fluid delivery members in the extended configuration of McGuckin ‘238 to be in a range of about 1 mm to about 10 mm as an obvious matter of design choice within the skill of the art.
Regarding claim 124, modified McGuckin ‘238 teaches the device of claim 121. Modified McGuckin ‘238 further teaches further comprising an actuator (18 Fig 1) coupled to the proximal end of the elongate member (the plunger 18 is coupled to the proximal end of the needle 20 through the tubing 70 as shown in Fig 12, fluid would flow from the plunger to the proximal end of the needle, the plunger is also retained in place relative to the needle by the housing 12)and operably coupled to the fluid delivery mechanism (upon operation of the stopcock, fluid would either flow through the plunger 18 into tubing 70 or not flow), wherein engaging the actuator moves the plurality of fluid delivery members from the retracted configuration to the extended configuration ([0054] “rotation and axial movement (advancement/retraction) of plunger 18 rotates and moves the mounting tube 70 axially, which in turn rotates and moves the connected tines 24a-24d axially”) and wherein disengaging the actuator moves the plurality of fluid delivery members from the extended configuration to the retracted configuration (withdrawal of the plunger withdraws the tines, [0048] “the interaction of the release lever and finger to release the plunger to enable withdrawal of the tines, mounting tube and plunger from the needle and housing”).
Claim 125 is rejected under 35 U.S.C. 103 as being unpatentable over McGuckin ‘238, in view of Baudino (US 6,353,762 B1) and Thompson et al. (US 2005/0137575 A1).
Regarding claim 125, modified McGuckin ‘238 teaches the device of claim 121. McGuckin ‘238 further discloses one or more fluid sources ([0066] “saline” “acetic acid”) fluidically coupled to one or more of the fluid delivery lumens or one or more of a plurality of fluid delivery channels ([0054] “This enables ethanol (or other ablation fluid) to flow around the mounting pin 72 and through the tines 24a-24d for delivery to the patient.”).
However, modified McGuckin ‘238 is silent to the fluid sources are cartridges.
Thompson et al. teaches a fluid source is a cartridge ([0005] “a cartridge containing a therapeutic agent to be injected into the tissue site”). It would have been obvious to one of ordinary skill in the art at the time of effective filing for the fluid source in the device of modified McGuckin ‘238 to be a cartridge to provide a therapeutic fluid in a predetermined volume [0005].
Claim 126 is rejected under 35 U.S.C. 103 as being unpatentable over McGuckin ‘238, in view of Baudino (US 6,353,762 B1) and De Haas (US 2016/0193365 A1).
Regarding claim 126, modified McGuckin ‘238 discloses the device of claim 121. However, modified McGuckin ‘238 is silent to further comprising a population of fluorescent tracking microspheres (FTM).
De Haas teaches a population of fluorescent tracking microspheres (FTM) ([0004] “fluorescent dye encapsulated by polymeric microspheres”). It would have been obvious to one of ordinary skill in the art at the time of effective filing for the device of modified McGuckin ‘238 to include a population of FTM as taught by de Haas to provide material for “marking tissue (e.g., healthy tissue or lesions) or lymph nodes of interest that is stable, exhibits minimal degradation, and does not migrate once it is introduced to the tissue or lymph node of interest.” [0003]
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/A.E.V./Examiner, Art Unit 3783
/COURTNEY B FREDRICKSON/Primary Examiner, Art Unit 3783