DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Response to Arguments
The drawings were received on 4/22/2026. These drawings are acceptable, and the objection has been withdrawn.
The previous objection of claims 4, 8 and 12 due to minor informalities has been withdrawn in light of applicant’s amendments made 4/22/2026.
The previous rejection of claim(s) 7 over 35 U.S.C. 112(b) as being indefinite has been overcome in light of the amendments made to claim(s) 7 on 4/22/2026.
The rejection of claims 1-4, 6, 8-10 and 12-15 under 35 U.S.C. 103 as being obvious over Suarez et al. (US 2010/0168723 A1) in view of Bradley et al. (US 2011/0004215 A1) in view of Muniz-Medina et al. (US 2011/0301578 A1) has been withdrawn in light of applicant’s amendment made 4/22/2026. Specifically, Muniz-Medina does not teach a first circuit mounted to the removable guard. Instead, the first circuit is mounted to the cutting accessory.
Applicant’s arguments with respect to claims 1-3 and 5-15 have been considered but are moot because the new ground of rejection does not rely on any reference in the prior art rejection of record for any teaching or matter specifically challenged in the argument. However, as discussed below, the newly added reference Miller et al. (US 2008/0188813 A1) teaches said limitation.
Claim Objections
Claim 8 is objected to because of the following informalities: Claim 8 recites “wherein the axial connector being moveable” in lines 7-8 which appears to have grammatical issues and should recite either “wherein the axial connector is moveable” or “the axial connector being moveable.” Appropriate correction is required.
Claim 12 is objected to because of the following informalities: Claim 12 recites “the axis” in line 6 which should read “the axis of the nose tube”. Appropriate correction is required.
Claim 24 is objected to because of the following informalities: Claim 24 recites “the axis” in line 6 which should read “the axis of the nose tube”. Appropriate correction is required.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: a mounting fixture in claims 10, 12-13 and 24.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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 pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter 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 pre-AIA 35 U.S.C. 103(a) 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 1-3, 6, 8-10 and 12-15 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Suarez et al. (US 2010/0168723 A1) in view of Bradley et al. (US 2011/0004215 A1) in view of Muniz-Medina et al. (US 2011/0301578 A1) in view of Miller et al. (US 2008/0188813 A1).
Regarding claims 1-2, Suarez discloses an end effector (end effector 100; Fig. 1) of a surgical robotic manipulator (robotic surgical system 20), the end effector (100) comprising: a nose tube (collet nut 532; Fig. 3; [0054]) extending along an axis (see line through 532 in Fig. 3); a rotatable cutting accessory (including at least tool bit 400 rotatable with the drive shaft 514, support tube 522, and collet 530; Fig. 3; [0041]) releasably coupled to the nose tube (532) for cutting tissue of a patient (as 522 is releasably secured to the main body 202 via 528; [0054]; and 400 is removably attached to the motor 500 via a first attachment mechanism within housing 200; [0032]); an actuator (drive actuator or user interface; [0038]) coupled to the cutting accessory when the cutting accessory is coupled to the nose tube (Figs. 1-3) for rotatably driving the cutting accessory (as 502 is a drive actuator that controls operation of the motor 500 which rotates 400; [0038]).
Suarez fails to disclose a removeable guard releasably coupled to the cutting accessory for covering a portion of the cutting accessory; and a first circuit mounted to one of the cutting accessory or the removable guard and a second circuit mounted to the nose tube, the first circuit and the second circuit configured to communicate with each other, wherein the first circuit is a radiofrequency identification circuit and wherein the second circuit is a radiofrequency identification reader.
However, Bradley teaches an end effector (Fig. 18) comprising a rotatable cutting accessory (rotary abrader 200) and a removeable guard (hood or guard 79; Figs. 1-5, 17-18) releasably coupled to the cutting accessory (as hood 79 may be removably interchangeable with other hoods; [0048]); for covering a portion of the cutting accessory ([0047]-[0048]) for the purpose of preventing inadvertent damage to tissue in close proximity to the tissue being abraded ([0005]).
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 rotatable cutting accessory of Suarez to include the removable guard as taught by Bradley in order to prevent inadvertent damage to tissue in close proximity to the tissue being abraded.
Modified Suarez fails to disclose a first circuit mounted to the removable guard and a second circuit mounted to the nose tube, the first circuit and the second circuit configured to communicate with each other.
However, Muniz-Medina teaches an end effector (surgical tool arrangement 10; Fig. 1) comprising a nose tube (coupling assembly 52 including collet 53) extending along an axis (Figs. 1-2); a cutting accessory (mechanical cutting instrument 13 which is selectively used in place of tool 12 on handpiece 11; [0044]; Figs. 1, 13) releasably coupled to the nose tube (52, 53; [0044]); and a first circuit (radio-frequency identification device) mounted to the cutting accessory (RFID 331 is disposed in instrument 13; [0055]; [0094]) and a second circuit (flexible circuit assembly 110) mounted to the nose tube (as 110 is a loop 111 and coil 112 that fits over the neck 56 of collet 53; Figs. 2-3; [0055]), the first circuit and the second circuit configured to communicate with each other (as coil 112 facilitates inductive signal transfer to/from the RFID in instrument 13; [0055]) for the purpose of identifying the cutting accessory, tool parameters, default settings, operation restrictions, etc. ([0094]), wherein the first circuit is a radiofrequency identification circuit (RFID 331), wherein the second circuit is a radiofrequency identification reader (as coil 112 reads data provided from the RFID 331 in instrument 13; [0094]). The cutting assembly (13) includes a shroud (hub assembly 300) and the first circuit (331) is disposed on a surface of the shroud (Fig. 14).
Miller teaches an end effector (including at least cartridge 150 and needle; Fig. 7; [0088]) comprising: a cutting accessory (needle; [0088]); a nose tube (cartridge holder 151 and nut 160) extending along an axis (Fig. 7); a removeable guard (cover or cap 108) releasably coupled to the cutting accessory for covering a portion of the cutting accessory (Fig. 7); and a first circuit (switches 164) mounted to the removable guard (Fig. 7) and a second circuit (switches 162) mounted to the nose tube (Fig. 7), the first circuit and the second circuit configured to communicate with each other (as the switches act as communication means arranged to transmit information to an external data receiving device; claim 2). The communication means may comprise wireless electrical conductors such as radiofrequency identification (RFID; [0033]-[0034]). Accordingly, it was known in the art to have RFID circuits on either a cutting accessory or a removeable guard of the cutting accessory.
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 end effector of modified Suarez such that the removeable guard includes a RFID circuit and the nose tube includes a RFID reader in light of the teachings of Muniz-Medina and Miller in order to identify the end effector prior to use, tool parameters, default settings, operation restrictions, etc.
Regarding claim 3, modified Suarez discloses wherein the first circuit (RFID 331 of Muniz-Medina) includes identification data identifying parameters of the cutting accessory, the identification data including at least one of a type, a size, a manufacturer, and/or a life use data of the cutting accessory (as data read by the coil 112 from the RFID 331 includes information which identifies the tool i.e. identifies the “type” of tool; [0094] of Muniz-Medina).
Regarding claim 6, modified Suarez discloses wherein the second circuit (112 of Muniz-Medina) is configured to receive a data from the first circuit (331 of Muniz-Medina) and transfer the data to the surgical robotic manipulator so that the surgical robotic manipulator can utilize the data to operate the end effector (as data from 331 read by 117 is sent to the control unit and the control unit of Muniz-Medina is equivalent to the surgical robotic manipulator of Suarez as it controls the end effector and delivers appropriate power levels to the tool to perform the desired procedure on the patient; [0045]; [0094]).
Regarding claim 8, modified Suarez discloses the invention as claimed above, and Suarez further discloses a drive connector (drive shaft 514) configured to rotatably drive a shaft (shaft of 400) of the cutting accessory ([0041]); a clutch assembly (opening within drive shaft 514; Fig. 4) supported by and selectively rotatable relative to the drive connector and receiving the shaft of the cutting accessory along the axis of the shaft for selectively locking the shaft to the drive connector (as the base or shank 404 of 44 is received within the drive shaft 514; [0041]); an axial connector (collar 518) disposed about the axis extending along the nose tube (Figs. 3-4) and capable of releasably locking and unlocking the cutting accessory to the nose tube ([0042]); and wherein the axial connector (518) being moveable along the axis extending along the nose tube between a locked position retaining the cutting accessory and an unlocked position releasing the cutting accessory ([0042]).
Regarding claim 9, modified Suarez discloses the invention as claimed above, and Suarez further discloses a handle (hand switch 502 and/or housing 200) coupled to the nose tube (Fig. 4), the handle rotatable about the nose tube (as 502 is rotatable; Figs. 4-5).
Regarding claim 10, modified Suarez discloses a handle (main body 202); a mounting fixture (interpreted under 112(f) as a mount as shown in Fig. 3 and equivalents thereof and Suarez discloses a mount 214; Figs. 2, 4) configured to couple the handle to the surgical robotic manipulator ([0034]); a lever (hand switch 502) supported by the handle and pivotable relative to the handle between a depressed position (Fig. 5) and a released position (Fig. 4); a sensor (second sensor element) operatively coupled to the nose tube (as the second senor element is on the main body 202 which holds 532; [0039]); and an activator (magnet 512) moveable relative to the sensor between a first position (when 502 is depressed; Fig. 5) and a second position (when 502 is released; Fig. 4) in response to movement of the lever (502) between the depressed position and the released position (Figs. 4-5); and wherein, in response to the lever being in the depressed position, the activator is in the first position and the sensor is spaced from the activator by a first distance such that the activator interacts with the sensor to enable activation of the actuator (Fig. 5; [0039]); and wherein, in response to the lever being in the released position, the activator is in the second position and the sensor is spaced from the activator by a second distance to enable deactivation of the actuator (Fig. 4; [0039]).
Regarding claim 12, modified Suarez discloses the invention as claimed above, and Suarez further discloses a handle (main body 202) including a mounting fixture (interpreted under 112(f) as a mount as shown in Fig. 3 and equivalents thereof and Suarez discloses a mount 214; Figs. 2, 4) configured to couple the end effector to the surgical robotic manipulator ([0034]); a lever (hand switch 502) coupled to the handle about a pivot point and pivotable about the pivot point between a depressed position (Fig. 5) and a released position (Fig. 4) for manual operation of the actuator, the pivot point being fixed to the handle about the axis (Figs. 4-5); and a sensor (second sensor element) supported by the nose tube (as second sensor is positioned on the main body 202 which holds 532) and configured to identify the position of the lever in the depressed position and the released position ([0039]); wherein the handle is rotatably supported by the nose tube such that the handle can rotate about the axis of the nose tube (Figs. 4-5).
Regarding claims 13-14, Suarez discloses a surgical robotic system (robotic surgical system 20; Fig. 2) comprising: a surgical robotic manipulator (articulated robotic arm 24) comprising a controller (computer aided navigation system and tracking device; [0029]); an end effector (end effector 100; Fig. 1) coupleable to the surgical robotic manipulator (Fig. 2), the end effector comprising: a handle (housing 200); a mounting fixture (interpreted under 112(f) as a mount as shown in Fig. 3 of applicant’s invention and equivalents thereof and Suarez discloses a mount 214; Figs. 2, 4) configured to couple the handle to the surgical robotic manipulator ([0034]); a nose tube (collet nut 532) extending along an axis (axis along the line shown in Fig. 3); a rotatable cutting accessory (including at least tool bit 400 rotatable with the drive shaft 514, support tube 522, and collet 530; Fig. 3; [0041]) releasably coupled to the nose tube (532) for cutting tissue of a patient (as 522 is releasably secured to the main body 202 via 528; [0054]; and 400 is removably attached to the motor 500 via a first attachment mechanism within housing 200; [0032]); an actuator (drive actuator or user interface; [0038]) coupled to the cutting accessory when the cutting accessory is coupled to the nose tube (532) for rotatably driving the cutting accessory ([0038]).
Suarez fails to disclose a removeable guard releasably coupled to the cutting accessory for covering a portion of the cutting accessory; and a first circuit mounted to one of the cutting accessory or the removable guard; and a second circuit mounted to the nose tube; wherein the first circuit is configured to communicate data to the second circuit configured to communicate with each other; and wherein the second circuit is configured to transfer the data from the first circuit to the controller of the surgical robotic manipulator; wherein the controller is configured to use the data to operate the end effector, wherein the data of the first circuit includes identification data identifying parameters of the cutting accessory.
However, Bradley teaches an end effector (Fig. 18) comprising a rotatable cutting accessory (rotary abrader 200) and a removeable guard (hood or guard 79; Figs. 1-5, 17-18) releasably coupled to the cutting accessory (as hood 79 may be removably interchangeable with other hoods; [0048]) for covering a portion of the cutting accessory ([0047]-[0048]) for the purpose of preventing inadvertent damage to tissue in close proximity to the tissue being abraded ([0005]).
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 rotatable cutting accessory of Suarez to include the removable guard as taught by Bradley in order to prevent inadvertent damage to tissue in close proximity to the tissue being abraded.
Modified Suarez fails to disclose a first circuit mounted to the removable guard; and a second circuit mounted to the nose tube; wherein the first circuit is configured to communicate data to the second circuit configured to communicate with each other; and wherein the second circuit is configured to transfer the data from the first circuit to the controller of the surgical robotic manipulator; wherein the controller is configured to use the data to operate the end effector, wherein the data of the first circuit includes identification data identifying parameters of the cutting accessory.
However, Muniz-Medina teaches an end effector (surgical tool arrangement 10; Fig. 1) comprising a nose tube (coupling assembly 52 including collet 53) extending along an axis (Figs. 1-2); a cutting accessory (mechanical cutting instrument 13 which is selectively used in place of tool 12 on handpiece 11; [0044]; Figs. 1, 13) releasably coupled to the nose tube (52, 53; [0044]); and a first circuit (radio-frequency identification device) mounted to the cutting accessory (RFID 331 is disposed in instrument 13; [0055]; [0094]) and a second circuit (flexible circuit assembly 110, 111, 112) mounted to the nose tube (as 110 is a loop 111 and coil 112 that fits over the neck 56 of collet 53; Figs. 2-3; [0055]), wherein the first circuit is configured to communicated data to the second circuit configured to communicate with each other (as coil 112 facilitates inductive signal transfer to/from the RFID in instrument 13; [0055]); and wherein the second circuit (112) is configured to transfer the data from the first circuit to a controller (control unit) for the purpose of identifying the cutting accessory, tool parameters, default settings, operation restrictions, etc. ([0094]), wherein the first circuit is a radiofrequency identification circuit (RFID 331), wherein the second circuit is a radiofrequency identification reader (as coil 112 reads data provided from the RFID 331 in instrument 13; [0094]).
Miller teaches an end effector (including at least cartridge 150 and needle; Fig. 7; [0088]) comprising: a cutting accessory (needle; [0088]); a nose tube (cartridge holder 151 and nut 160) extending along an axis (Fig. 7); a removeable guard (cover or cap 108) releasably coupled to the cutting accessory for covering a portion of the cutting accessory (Fig. 7); and a first circuit (switches 164) mounted to the removable guard (Fig. 7) and a second circuit (switches 162) mounted to the nose tube (Fig. 7), the first circuit and the second circuit configured to communicate with each other (as the switches act as communication means arranged to transmit information to an external data receiving device; claim 2). The communication means may comprise wireless electrical conductors such as radiofrequency identification (RFID; [0033]-[0034]). Accordingly, it was known in the art to have RFID circuits on either a cutting accessory or a removeable guard of the cutting accessory.
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 end effector of modified Suarez such that the removeable guard includes a RFID circuit and the nose tube includes a RFID reader in light of the teachings of Muniz-Medina and Miller in order to identify the end effector prior to use, tool parameters, default settings, operation restrictions, etc.
Regarding claim 15, modified Suarez discloses the invention as claimed above, and Suarez further discloses wherein the handle (200) is coupled to the nose tube (532) such that the handle is rotatable about the nose tube (as hand switch 502 of housing 200 pivots relative to 532; Figs. 4-5).
Allowable Subject Matter
Claims 5, 7 and 11 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Claims 21-25 are allowed.
The following is a statement of reasons for the indication of allowable subject matter: With respect to claims 5 and 21, the guard (79) of Bradley et al. (US 2011/0004215 A1) does not comprise an outer member and an inner member, the inner member slideably engaged with the outer member; wherein the inner member is slideable within a bore defined by the outer member between an extended position and a compressed position as claimed nor would it be capable of engaging and disengaging the cutting accessory with the nose tube.
With respect to claim 7, Frost (US 4,517,977) teaches a rotational drive member (17) defining a lumen (35) for receiving fluid (Fig. 1); a drive connector (32) coupled to the rotational drive member (via lugs 33) and engaging a cutting accessory (14), but the fluid delivery member (19) is not coupled to the rotational drive member as fluid within the cutting accessory is removed rather than delivered to the lumen of the rotational drive member. Perez et al. (US 6,132,448) teaches a fluid delivery member (19) but fails to disclose the rotational drive member and seals as claimed. Further modifying Suarez with the fluid delivery member as claimed would require a substantial reconstruction and redesign of the elements shown in Suarez.
Regarding claim 11, Suarez fails to disclose a carriage coupled to the nose tube; wherein the activator is disposed on the carriage and configured to move along the axis of the nose tube in response to movement of the lever between the depressed position and the released position. Instead, the activator (512) is disposed on the lever (520) such that it moves on an axis perpendicular to that of the nose cone (532; Figs. 4-5).
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARAH A LONG whose telephone number is (571)270-3865. The examiner can normally be reached Monday-Friday 9am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Elizabeth Houston can be reached at (571)272-7134. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SARAH A LONG/Primary Examiner, Art Unit 3771