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 .
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 119(e) and 120 as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original non-provisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994)
The disclosure of the prior-filed application, Application Nos. 61800527 and 61662702, fail to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. Specifically, neither of Applications Nos. 61800527 and 61662702 teach the claimed locking mechanism with clams shells (e.g. claims 13, 14), e.g. Figures 17A-17H of the instant application are not present in the prior-filed applications 61800527 and 61662702.
As such, the instant claims are awarded the effective filing date of the earliest disclosure of the claimed invention which is that of parent application 13924505 and corresponds to June 21, 2013.
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 limitations use 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 limitations are: “stop mechanism” (claims 1 and 15), "release mechanism" (claim 12), and "locking mechanism" (claim 13).
Because these claim limitations are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, they are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
The “stop mechanism” (claims 1 and 15) is element 52, Fig. 17A-17B; par. 0080; 46, Fig. 17C-17E, which is a mechanical abutment between the guide tube and the drill bit.
The "release mechanism" (claim 12) is element 48, Fig. 17C-17E.
The “locking mechanism” (claim 13) is an arrangement of two clam shells as in 49, Figures 17F-17H.
If applicant does not intend to have these limitations 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 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 limitations recite sufficient structure to perform the claimed function so as to avoid 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 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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, 10 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over US 2006/0036264 to Selover in view of US 6246200 to Blumenkranz.
Regarding Claim 1, Selover discloses a method of planning a surgery using a surgical robot system (abstract), said method comprising:
planning a desired trajectory for a surgical instrument to reach a desired anatomical target (par. 0030, a trajectory is selected based on imaging data); and
moving the surgical robot system to a position corresponding to the desired trajectory for the surgical instrument (the robot arm is moved to align with the selected trajectory and locked into place along the trajectory, par. 0033-0034),
wherein the surgical robot system includes:
a surgical robot having a controllable robot arm (robot arm 42, fig. 1, 5), the robot arm having an end effectuator comprising a guide tube (cannula 46 is a type of guide tube, fig. 1-2, 5); and
a surgical instrument configured to be positioned through the guide tube and configured to be advanced into tissue of a patient (drill bit, par. 0067);
wherein the surgical instrument comprises a stop mechanism configured to prevent the surgical instrument from advancing through the guide tube when the surgical instrument reaches a predetermined amount of protrusion (mechanical stop abutment, par. 0043; the corresponding protrusion on the instrument is a stop on the instrument; “protrusion” is considered synonymous with “stop” in this instance).
Selover does not specifically teach wherein the end-effectuator includes a clearance mechanism including an actuator that is coupled to the guide tube by two shafts, and wherein the position of the guide tube can mimic the position of the end-effectuator.
Instead, Selover teaches the end effector is actuated using a ball joint (48, Figures 1-2; par. 0035), and Selover also acknowledges that “any suitable means” may be used (par. 0035).
Blumenkranz teaches a surgical robot arm wherein the end-effectuator includes a clearance mechanism including an actuator (motors 70, col. 7, lines 58-67) that is coupled to the guide tube by two shafts (parallelogram linkage with two shafts 62, Figure 2B, col. 7, lines 36-49), and wherein the position of the guide tube can mimic the position of the end-effectuator (when the end effectuator is rotated, the guide tube is rotated around the remote center 64, col. 7, lines 45-49).
One of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to utilize the parallelogram linkage of Blumenkranz in the system of Selover in order to smoothly align pitch and yaw axis at the remote center along the shaft of the guide tube, for improved positioning in a surgical robotic arm as taught by Blumenkranz (col. 7, lines 36-49).
Regarding Claim 10, Selover further discloses wherein the surgical instrument is a drill bit (drill bit, par. 0067) and the drill bit includes the stop mechanism (par. 0043, the corresponding protrusion on the instrument is a stop on the instrument/drill bit; “protrusion” is considered synonymous with “stop” in this instance).
Claim 15 (which is broader than claim 1) is rejected for the same reasoning as for claim 1 above.
Claims 2-6 and 16-20 are rejected under 35 U.S.C. 103 as being unpatentable over US 2006/0036264 to Selover in view of US 6246200 to Blumenkranz, as applied to claims 1 and 15 above, in further view of US 2010/0274256 to Ritchey.
Regarding Claim 2-6, although Selover teaches a drill stop (par. 0043), Selover does not disclose how the maximum protrusion distance is determined or monitoring of the protrusion distance.
Similar to Selover, Ritchey teaches a tracked drill guide tube (24, fig. 1, 9; par. 0097) for a drill bit (90, fig. 9). Ritchey also teaches a stop mechanism on the drill to prevent the drill from advancing through the guide tube when the surgical instrument reaches a predetermined amount of protrusion (when the drill 1016 is attached to the drill bit 1018 as shown in fig. 25, a stop collar is implicitly formed 1020). Ritchey further teaches wherein a sensor (19, fig. 9) is able to determine a protrusion distance past an end of the guide tube that the drill bit protrudes (the drill bit has position markings 92 that are sensed by a sensor 19 in the guide tube, fig. 9, par. 0115), wherein the protrusion distance is determined and monitored from known lengths of the guide tube and the surgical instrument and a known location where the sensor is attached to the guide tube (analogous to calipers to measure distance, par. 0115; there is an inherent knowledge of guide tube length, drill bit length relative to the sensor position in order make the protrusion determination, for example, when the sensors 19/92 coincide, the system knows the drill bit is at the end of the guide tube, and as the drill bit is further inserted, displacement is measured and protrusion distance is determined as the displacement, par. 0152-0153). Ritchey teaches displacement/protrusion sensors comprising a capacitive sensor array (stator and wiper/slider, par. 0152, fig. 32), a jig with markings (par. 0153), an optical linear encoder (fig. 33, par. 0154), or sensor coils (par. 0155, fig. 34) for continuously monitoring the displacement/protrusion distance of the drill bit. Further, the protrusion distance is displayed on a display (distance measurement is sent to the control unit and displayed on the monitor, par. 0154 and 0155).
One of ordinary skill in the art before the effective filing date of the invention would have found it obvious to provide the drill bit protrusion measurement of Ritchey in the system of Selover in order to provide improved guidance of the drill bit advancement for orthopedic applications, in particular to provide guided advancement of the drill for the surgeon to view as it approaches the target anatomy.
Claims 16-20 are rejected for the same reasoning as for claims 2-6 above.
Claims 7-9 are rejected under 35 U.S.C. 103 as being unpatentable over US 2006/0036264 to Selover in view of US 6246200 to Blumenkranz and US 2010/0274256 to Ritchey as applied to Claim 5 above, in further view of US 20050222571 to Ryan.
Regarding Claims 7-9, Selover in view of Ritchey teaches a sensor pad having a coupled wiper (Ritchey: stator and wiper/slider, par. 0152, fig. 32) and when the wiper moves across the sensor pad, a linear position of the wiper is sampled, thereby permitting calculation of the actual protrusion distance (distance measurement is sent to the control unit and displayed on the monitor, par. 0154 and 0155), but does not teach a spring-loaded plunger including a spring-loaded mechanism.
Ryan teaches an adjustable depth drill bit wherein a stop mechanism on the drill bit is manually adjustable on the drill bit (par. 0083-0086) in order to set the desired drill depth/protrusion into the bone. Ryan’s stop mechanism is spring-loaded (compression spring 206, fig. 2) in order to bias the drill bit 100 in the proximal direction to maintain the distal portion of the drill bit within the distal housing 202 (par. 0052-0056). The stop mechanism is configured to engage the spring-loaded mechanism (i.e. bias) before it encounters the end of the guide tube (compression spring 206, fig. 2; 0052-0056).
One of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to include Ryan’s spring-loaded mechanism in the drill stop of Selover in order to bias the drill bit in the proximal direction so as to provide controlled movement of the drill bit.
Claims 11-13 are rejected under 35 U.S.C. 103 as being unpatentable over US 2006/0036264 to Selover in view of US 6246200 to Blumenkranz, as applied to claim 1 above, in further view of US 2005/0222571 to Ryan.
Regarding Claim 11, Selover does not teach wherein the stop mechanism on the drill bit is manually adjustable with reference to markings on the drill bit.
Ryan teaches an adjustable depth drill bit wherein a stop mechanism on the drill bit is manually adjustable on the drill bit (par. 0083-0086) in order to set the desired drill depth/protrusion into the bone.
One of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to provide the adjustable stop mechanism of Ryan as the stop mechanism of Selover so as to provide the ability to set the desired drill depth/protrusion into the bone for the corresponding medical instrumentation and tissue target.
Regarding Claim 12, Selover does not teach wherein the drill bit includes release mechanisms on each end of the stop mechanism.
Ryan further teaches release mechanisms to release the stop mechanism from the drill bit, wherein the release mechanism is configured to be pulled in order to allow the drill stop to move along a shaft of the drill bit (par. 0084-0085).
One of ordinary skill in the art before the effective filing date of the invention would have found it obvious to provide the release mechanism of Ryan in the system of Selover in order to provide the predictable result of an adjustable depth drill bit for precisely setting the desired drill protrusion into the bone as taught by Ryan.
Regarding Claim 13, Selover does not teach wherein the drill bit includes a locking mechanism configured to lock and hold the drill bit in a set position relative to the guide tube.
Ryan teaches wherein the drill bit includes a locking mechanism configured to lock and hold the drill bit in a set position relative to the stop mechanism (locking sleeves 304, fig. 15-16, par. 0084-0085).
One of ordinary skill in the art before the effective filing date of the invention would have found it obvious to provide the locking mechanism of Ryan in the system of Selover in order to provide the predictable result of an adjustable depth drill bit for precisely setting the desired drill protrusion into the bone as taught by Ryan.
Claims 14 are rejected under 35 U.S.C. 103 as being unpatentable over US 2006/0036264 to Selover in view of US 6246200 to Blumenkranz and US 2005/0222571 to Ryan, as applied to claim 13 above, in further view of US 9,505,063 to Santamarina.
Regarding Claim 14, Selover in view of Ryan does not teach wherein the locking mechanism includes two clam shells, and the drill bit is locked into position by closing the clam shells around the stop mechanism.
Instead, Ryan teaches locking sleeves that lock the drill bit into position by closing around the stop mechanism (fig. 15-16, par. 0084-0085). The locking sleeves are slid linearly with respect to the longitudinal axis of the drill bit to releasably engage the stop mechanism. This linear actuation appears to be equal in function to that of removing the sleeves (i.e. clam-shell/two halves), as taught by Santamarina to be for the same purpose of providing an adjustable drill stop (fig. 37-43 show the clam-shell configuration, col. 16, lines 65 – col. 17, line 9).
As such, one of ordinary skill in the art before the effective filing date of the invention would have found it an obvious matter of design choice to provide either fully removable locking sleeves (i.e. clam-shell design) as taught by Santamarina or linearly actuated sleeves in the system of Ryan in order to permit unlocking/locking of the adjustable stop mechanism. One of ordinary skill in the art would have been motivated to select the clam-shell design in order to prevent tampering during use and/or to prevent dirt from entering the locking mechanism after it has been set.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of U.S. Patent No. 11191598. Although the claims at issue are not identical, they are not patentably distinct from each other because the patented claims are the device that is being used by the instant method claims. The patented device is narrower in scope than the instant claimed and therefore necessarily anticipate the claimed device. The method steps are of the instant claims (i.e. claim 1 planning a trajectory and moving the surgical robot) are taught by Selover as in the rejection above. As such, it would be obvious to one of ordinary skill in the art to utilize the patented device in the method of Selover in order to perform robotic surgery. The following is a correspondence of the claims:
Instant Claims
Patented Claims
1
1+Selover
2, 3, 4
2
5, 6
4
7
3
8
5
9
6
10, 11
7
12
8
13, 14
1
15
9+Selover
16
10
17, 18
11
19
12
20
13
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-20 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. US 6246200 to Blumenkranz is now cited to address the newly added features related to the robotic linkage.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. US 5817084, 6758843, 5800423 to Jensen, US 20080314181 to Schena teach parallelogram linkages that read on the claimed clearance mechanism.
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 ANGELA MARIE HOFFA whose telephone number is (571)270-7408. The examiner can normally be reached Monday - Friday 9:30 am - 6:00 pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Keith Raymond can be reached at (571)270-1790. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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ANGELA M. HOFFA
Primary Examiner
Art Unit 3799
/Angela M Hoffa/Primary Examiner, Art Unit 3799