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 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.
Claim 7 recites “cap separation preventing means” without structural elements to perform the recited function.
Claim 1 recites “a chuck device.” Under broadest reasonable interpretation and in light of the written description, “a chuck device” is interpreted to mean a device that securely holds an object.
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.
Claim 1-8 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.
Claim 1 recites “a sleeve supporting a medical tool comprising a shaft.” It is unclear if the sleeve or medical tool comprises a shaft. For the purpose of continued examination, medical tool is interpreted to comprise a shaft.
Claim 1 recites the limitation "coupling with the sleeve comprising the shaft.” There is insufficient antecedent basis for this limitation in the claim.
Claim 1 recites “installed with a calibration tool.” It is unclear if claim 1 requires the calibration tool or if the calibration tool is a functional recitation. For the purpose of continued examination, “installed with a calibration tool” is interpreted as a functional recitation. Dependent claims inherit the same deficiencies.
Claim 8 recites the limitation "the first support bearing.” There is insufficient antecedent basis for this limitation in the claim. It is also unclear which first support bearing is recited.
Claim 8 recites the limitation "the second support bearing.” There is insufficient antecedent basis for this limitation in the claim. It is also unclear which second support bearing is recited.
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.
Claim(s) 1-4, 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Walen et al (International Publication WO 2022/180610 A2) in view of Song et al (International Publication KR 20140072302 A).
Regarding claim 1, Walen teaches a surgical device, comprising:
a sleeve (404, Fig. 11C) supporting a medical tool comprising a shaft (304, Fig. 11C) ([0109]; distal member 404 (sleeve) and shaft 304);
a chuck device part (178, Fig. 11C) coupling with the sleeve comprising the shaft ([0105], Fig. 11C; receiver 178 (chuck) coupled to distal member 404 (sleeve));
a holder part (408, Fig. 13A) installed with the chuck device part ([0109]; tracker mount 408 (holder) installed with distal member 404 (sleeve) and proximal member 406) and mounted to a distal end,
a calibration mounting part (418, Fig. 11C & 13A) detachably provided in the sleeve ([0128]; coupler 418 (mounting part)) and installed with a calibration tool (601, Fig. 12) ([0149]; calibration block 601),
but does not teach,
and mounted to a distal end of a robot arm,
as claimed.
However, Song teaches a system and a method for a joint cutting system using a robotic arm. Song is analogous to the claimed invention because it is reasonably pertinent to the problem of mounting attachments to a robotic arm.
Song further teaches,
and mounted to a distal end of a robot arm ([0005]; cutter mounted on distal end of robot arm).
It would have been obvious for one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the system, as taught by Walen, with a device mounted to a distal end of a robot arm, as taught by Song. One of ordinary skill in the art would have been motivated to make these modifications to improve surgical treatment by utilizing robot-assisted surgical methods that are controlled by a computer (Song, [0005]).
Regarding claim 2, Walen, in view of Song, teaches the surgical device of claim 1, and further teaches wherein the calibration mounting part comprises:
a calibration mounting member (302, Fig. 11C) mounted to the sleeve ([0127]; calibration body 302 mounted to distal member 404 (sleeve)),
but does not disclose,
a holding cap member fastened to the sleeve; and
a calibration mounting member mounted to the sleeve by the holding cap member,
as claimed.
However, Song teaches,
a holding cap member (22, Fig. 7a) fastened to the sleeve ([0041], Fig. 5b; sleeve body 212 (sleeve) fastened to sleeve base 22 (holding cap member)); and
a member (23, Fig. 5b) mounted to the sleeve by the holding cap member ([0041]; sealing seal 23 (a member) attached to sleeve 212 (sleeve) with support from inner wall of sleeve base 22 (holding cap member)).
It would have been obvious for one of ordinary skill in the art prior to the effective filing date of the claimed invention to further modify the system, as taught by Walen and Song, with a holding cap member fastened to the sleeve and a calibration mounting member mounted to the sleeve by the holding cap member. One of ordinary skill in the art would have been motivated to make these modifications to improve maintainability by mounting a cutting member to a sleeve with a holding cap member that enables each part to be replaced individually (Song, [0001]).
Regarding claim 3, Walen, in view of Song, teaches the surgical device of claim 2, and further teaches wherein
the calibration mounting member comprises a bar-shaped calibration shaft (304, Fig. 12) in which a marker is installed (606, Fig. 12, [0149]; calibration block 601 coupled to shaft 304 and comprises markers 606) and a position-setting member (310, Fig. 15) formed in the calibration shaft ([0140], Fig. 15; stop 310 configured to position adaptor 402 at a common distance from distal end 308),
the sleeve (404, Fig. 11C) comprises a hollow sleeve body, and a shaft insertion hole formed penetrating in a longitudinal direction ([0109]; distal member 404 (sleeve) receives shaft 310 through hollow sleeve opening (shaft insertion hole)),
but does not teach,
and seated on the holding cap member,
the sleeve comprises a hollow sleeve body formed with a coupling male-thread portion formed on an outer circumferential surface on one side, and
the holding cap member comprises a cap body shaped like a cap and connected to the hollow sleeve body, a rod insertion hole formed in the cap body to insert the calibration shaft therein formed on an inner circumferential surface of the cap body to be fastened to the coupling male-thread portion,
as claimed.
However, Song further teaches,
a mounting member (21, Fig. 5b) seated on the holding cap member (22, Fig. 7a) ([0051]; sleeve 21 (a mounting member) seated on sleeve base 22 (holding cap member)),
the sleeve comprises a hollow sleeve body (212, Fig. 5b, [0036]; sleeve body 212 with hollow hole 211) formed with a coupling male-thread portion (213a, Fig. 6) formed on an outer circumferential surface on one side ([0053]; sleeve fastening part 213a formed on outer rear end of sleeve 21), and a shaft insertion hole (211, Fig. 5b) formed penetrating in a longitudinal direction ([0036]; sleeve 21 has a hollow hole 211 (shaft insertion hole)), and
the holding cap member (22, Fig. 7a) comprises a cap body shaped like a cap and connected to the hollow sleeve body ([0053]; sleeve base 222 coupled to sleeve body 212), a rod insertion hole formed in the cap body (221, Fig. 7a) to insert the calibration shaft therein ([0052]; sleeve base 22 (holding cap member has hollow portion 221 (shaft insertion hole)), and a cap female thread (223, Fig. 7a) formed on an inner circumferential surface of the cap body to be fastened to the coupling male-thread portion ([0053]; first base fastening part 223 screw-coupled with sleeve fastening part 213a),
It would have been obvious for one of ordinary skill in the art prior to the effective filing date of the claimed invention to further modify the system, as taught by Walen and Song, with a calibration mounting member comprises a bar-shaped calibration shaft in which a marker is installed and a position-setting member formed in the calibration shaft and seated on the holding cap member, a sleeve comprises a hollow sleeve body formed with a coupling male-thread portion formed on an outer circumferential surface on one side, and a shaft insertion hole formed penetrating in a longitudinal direction, and, a holding cap member comprises a cap body shaped like a cap and connected to the hollow sleeve body, a rod insertion hole formed in the cap body to insert the calibration shaft therein formed on an inner circumferential surface of the cap body to be fastened to the coupling male-thread portion, as taught by Walen. One of ordinary skill in the art would have been motivated to make these modifications to improve surgical precision and accuracy by determining a position of a distal portion of an end effector (Walen, [0139]), and improve maintainability by mounting a calibration member to a sleeve with a holding cap member that enables each part to be replaced individually (Song, [0001]).
Regarding claim 4, Walen, in view of Song, teaches the surgical device of claim 3, and further teaches comprising a mounting member rotation blocking portion configured to block the movement of the calibration mounting member ([0138], Fig. 6b; compression of adapter 402 between stop 210 and proximal member 406 prevents rotation of distal member 404 thereby blocking movement of end effector 202).
Regarding claim 8, Walen, in view of Song, teaches the surgical device of claim 3, but does not disclose wherein,
the sleeve comprises a sleeve cap coupled to the shaft insertion hole corresponding to an outer free end of the hollow sleeve body; a plurality of first support bearings provided in the shaft insertion hole being in contact with the sleeve cap and supporting the shaft; a spacer formed having a cylindrical shape and provided being in contact with the first support bearing; a plurality of second support bearings provided being in contact with the spacer and supporting the shaft; and an airtight member inserted through a coupling female-thread portion formed inside the shaft insertion hole, and
the shaft insertion hole comprises a fitting groove to which the sleeve cap, the first and second support bearings, and the spacer are fitted; a locking protrusion to which the second support bearing is locked; and an airtight member insertion groove recessed at an inner end of the coupling female-thread portion and inserting the airtight member therein.
Song further teaches,
the sleeve comprises a sleeve cap (5, Fig. 6) coupled to the shaft insertion hole (211, Fig. 5b) corresponding to an outer free end of the hollow sleeve body ([0048]; end spacer 5 fitted into outer end of hollow hole 211); a plurality of first support bearings (34, Fig. 6) provided in the shaft insertion hole being in contact with the sleeve cap and supporting the shaft ([0046], Fig. 5b; support bearings 34 fitted to shaft 11); a spacer formed having a cylindrical shape (4, Fig. 6) and provided being in contact with the first support bearing ([0047]; spacer 4 between bearings 32 & 34); a plurality of second support bearings (32, Fig. 6) provided being in contact with the spacer and supporting the shaft ([0047]; spacer 4 between bearings 32 & 34); and
the shaft insertion hole comprises a fitting groove (214b, Fig. 5b) to which the sleeve cap, the first and second support bearings, and the spacer are fitted ([0044]; second bearing seating grooves 214b accommodate first and second support bearings and spacer); a locking protrusion to which the second support bearing is locked (215, Fig. 5b; reinforcing member 215 protrudes adjacent to bearings 32,
but does not disclose,
an airtight member inserted through a coupling female-thread portion formed inside the shaft insertion hole, and
an airtight member insertion groove recessed at an inner end of the coupling female-thread portion and inserting the airtight member therein,
as claimed.
However, Song further teaches a sleeve base 22 that attaches to sleeve 212 and comprises,
an airtight member (23, Fig. 5b) inserted through a coupling female-thread portion (224, Fig. 7a) formed inside the shaft insertion hole ([0054], Fig. 5b; sealing seal 23 inserted into sleeve base 22), and
an airtight member insertion groove recessed at an inner end of the coupling female-thread portion and inserting the airtight member therein (Fig. 5b; sealing member 23 inserted into recessed groove medial to second base fastening part 224 along longitudinal axis).
It would have been obvious for one of ordinary skill in the art prior to the effective filing date of the claimed invention to further modify the system, as taught by Walen and Song, with a sleeve comprises a sleeve cap coupled to the shaft insertion hole corresponding to an outer free end of the hollow sleeve body; a plurality of first support bearings provided in the shaft insertion hole being in contact with the sleeve cap and supporting the shaft; a spacer formed having a cylindrical shape and provided being in contact with the first support bearing; a plurality of second support bearings provided being in contact with the spacer and supporting the shaft; an airtight member inserted through a coupling female-thread portion formed inside the shaft insertion hole, and the shaft insertion hole comprises a fitting groove to which the sleeve cap, the first and second support bearings, and the spacer are fitted; a locking protrusion to which the second support bearing is locked; and an airtight member insertion groove recessed at an inner end of the coupling female-thread portion and inserting the airtight member therein. Furthermore, as the Federal Circuit in KSR has explained, “a finding that a combination of prior art would have been ‘common sense’ or ‘intuitive’ is no different than merely stating the combination ‘would have been obvious’”, such that applying a known technique to a known device ready for improvement to yield predictable results supports a conclusion of obviousness; sealing seal 23 and recess of prior art known to form an airtight seal between sleeve base 22 and a robotic arm. In addition, one of ordinary skill in the art would have been motivated to make these modifications to improve surgical treatment by reducing the diameter of the sleeve and using a combination of support bearings and spacers to support a medical tool (Song, [0013]) and to prevent debris and liquids from entering the robot arm by hermetically sealing detachable components (Song, [0041]).
Claim(s) 5, 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Walen et al (International Publication WO 2022/180610 A2), in view of Song et al (International Publication KR 20140072302 A) and in further view of Zhang et al (International Publication CN116370162A).
Regarding claim 5, Walen, in view of Song, teaches the surgical device of claim 4, but does not disclose wherein the mounting member rotation blocking portion comprises:
a pin insertion groove formed in the sleeve; and
a rotation blocking pin formed in the position-setting member and inserted in the pin insertion groove.
However, Zhang teaches a system and a method for implantation of a hip prosthesis. Zhang is analogous to the claimed invention because it is reasonably pertinent to the problem of using pins to secure and prevent rotation of device members.
Zhang further teaches wherein the mounting member rotation blocking portion comprises:
a pin insertion groove (222, Fig. 11) formed in the sleeve (22, Fig. 11) ([0065]; two locking grooves in nut 22); and
a rotation blocking pin (212, Fig. 11) formed in the position-setting member (213, Fig. 11) and inserted in the pin insertion groove ([0065]; flange 213 forms two locking blocks 212 which connect to locking grooves 222).
It would have been obvious for one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the system, as taught by Walen and Song, with a pin insertion groove formed in the sleeve and a rotation blocking pin formed in the position-setting member and inserted in the pin insertion groove, as taught by Zhang. One of ordinary skill in the art would have been motivated to make these modifications to improve device positioning by preventing connecting member rotation using locking blocks and grooves (Zhang, [0065]).
Regarding claim 7, Walen, in view of Song and Zhang, teaches the surgical device of claim 5, but does not disclose wherein
the calibration mounting member comprises a cap separation preventing means configured to prevent the holding cap member from being separated from the calibration shaft,
the position-setting member is shaped like a disc to be inserted in the holding cap member,
the rotation-blocking pin comprises a plurality of rotation-blocking pins protruding from the disc, and
the holding cap member is formed with an inspection opening to inspect an alignment state between the sleeve and the calibration mounting member in the cap body.
Zhang further teaches,
the calibration mounting member comprises a cap separation preventing means (25, Fig. 12) configured to prevent the holding cap member (27, Fig. 12) from being separated from the calibration shaft (21, Fig. 12) ([0063]; retainer 25 set inside adjusting member 27 and along with bottom wall prevent adjusting member 27 from separating from calibration shaft 21),
the position-setting member is shaped like a disc to be inserted in the holding cap member ([0061]; flange 213),
the rotation-blocking pin comprises a plurality of rotation-blocking pins protruding from the disc ([0061]; locking blocks protrude from flange 213),
but does not teach,
the holding cap member is formed with an inspection opening to inspect an alignment state between the sleeve and the calibration mounting member in the cap body.
However, Song further teaches,
the holding cap member (222, Fig. 5a) is formed with an inspection opening (225, Fig. 5b & 7b) to inspect an alignment state between the sleeve and the calibration mounting member in the cap body ([0051]; water discharge hole 225 in sleeve base 222).
It would have been obvious for one of ordinary skill in the art prior to the effective filing date of the claimed invention to further modify the system, as taught by Walen, Song, and Zhang, with a calibration mounting member comprises a cap separation preventing means configured to prevent the holding cap member from being separated from the calibration shaft, a position-setting member is shaped like a disc to be inserted in the holding cap member, a rotation-blocking pin comprises a plurality of rotation-blocking pins protruding from the disc, a holding cap member is formed with an inspection opening to inspect an alignment state between the sleeve and the calibration mounting member in the cap body, and a holding cap member is formed with an inspection opening to inspect an alignment state between the sleeve and the calibration mounting member in the cap body. One of ordinary skill in the art would have been motivated to make these modifications to improve device positioning by preventing connecting member rotation using locking blocks and grooves (Zhang, [0065]) and to improve device function by discharging water through a holding cap member to clean and cool a cutting surface (Song, [0055]).
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Walen et al (International Publication WO 2022/180610 A2) in view of Song et al (International Publication KR 20140072302 A), and in further view of Zhang et al (International Publication CN116370162A) and Forst et al (International Publication WO 2021/099843 A2).
Regarding claim 6, Walen, in view of Song and Zhang, teaches the surgical device of claim 5, but does not disclose wherein the pin insertion groove is structured to comprise a foreign substance discharging portion on one side to facilitate the discharge of foreign substances.
However, Forst teaches a system and a method for patient head stabilization. Forst is analogous to the claimed invention because it is reasonably pertinent to the problem of using pin grooves in medical devices.
Forst further teaches, wherein the pin insertion groove is structured to comprise a foreign substance discharging portion on one side (one of 126, Fig. 3 & 4) to facilitate the discharge of foreign substances ([00036]; pin insertion grooves are elongated slots 126 that can facilitate the discharge of foreign substances that fall into grooves).
It would have been obvious for one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the system, as taught by Walen, Song, and Zhang, with a pin insertion groove is structured to comprise a foreign substance discharging portion on one side to facilitate the discharge of foreign substances, as taught by Forst. One of ordinary skill in the art would have been motivated to make these modifications to adjust connecting member torque settings by using pin movement in an elongated slot to indicate force (Forst, [00036]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DWANE COLLARD whose telephone number is (571)272-6553. The examiner can normally be reached M-F 9 am-6 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Ben Klein can be reached at (571) 270-5213. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DWANE COLLARD/Examiner, Art Unit 3792
/William J Levicky/Primary Examiner, Art Unit 3796
