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 .
Response to Arguments
Applicant's arguments filed 06/25/2026 have been fully considered but they are not persuasive.
Applicant argues: the office asserts that pegs 2702, defining a bone anchor device, exhibits substantially identical structure to the claimed portion. The claim as currently amended require bone anchor device configured to be entirely received in a cavity of a bone.
Response: the office is of the position that the claim does not specify the boundary of the claimed “bone anchor device”, and therefore at least a portion of peg(s) 2702, which is intended to be received entirely into bone {see i.e. ¶148 of Chi, which in part states “two perpendicular pegs 2702 that are matched to the distal drill holes 1206”, is sufficient to read on the claimed bone anchor device configured to be entirely received in a cavity of a bone. Moreover, ¶160 of Chi in part states “The fixture 3909 mounted to the distal femur ” and Fig.39 shows that the plate 3909 is seated on the distal femur in a flush configuration. Accordingly, a PHOSITA considering the entirety of Chi would understand that pegs 2702 define at least a portion intended to be entirely received in a cavity of a bone.
Applicant argues: the claim requires that the bone anchor device to remain in the cavity of the bone post-surgery as an implanted device. Fixture 3909 is not and cannot be a bone anchor device, the only portion that penetrates bone are the pegs 2702.
Response: the office is of the position that Chi discloses the elements required by the claim, in this case, Chi discloses pegs 2702 having at least portion intended to be entirely received in a cavity of a bone. The fact the Chi discloses additional components connected to the pegs, i.e. fixture 3909 or 2701 are irrelevant. Moreover, with regards to leaving or temporary leaving or removing the anchor in the bone post-surgery does not add structure to the claimed anchor, wherein the anchor 2702 of Chi exhibits substantially identical structure to the claimed anchor, and exhibits a portion configured to be entirely received in a cavity of the bone. Therefore, the anchor of Chi is capable of performing the claimed functions, being leaving the anchor in the bone post-surgery, if one desire to do so, at least based on the structure similarities.
Applicant argues: the only portions of the fixture that penetrate the bone are the pegs 2702. Then, argues that pegs 2702 are small and are not configured to be received in a cavity of a bone in the manner required by the claims, they rest atop the bone.
Response: the office is of the position that it has been held that arguments presented by applicant cannot take the place of factually supported objective evidence. See, e.g., In re Schulze, 346 F.2d 600, 602, 145 USPQ 716, 718 (CCPA 1965); In re De Blauwe, 736 F.2d 699, 705, 222 USPQ 191, 196 (Fed. Cir. 1984).
In this case, Applicant already stated that the pegs are intended to penetrate bone, and Chi discloses in ¶148 that pegs 2702 are matched to the distal drill holes 1206. Accordingly, a PHOSITA considering the entirety of Chi would understand that pegs 2702 exhibits at least a portion configured to be entirely received in a cavity of the bone, as required by the claims, not a small peg to rest atop the bone as argued.
Applicant argues: pegs 2702 don’t contain receptacle, do not accommodate sensors, don’t include electronic circuitry for equating the pegs to the claimed bone anchor device.
Response: In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
Applicant argues: pegs 2702 are integral to the system, the pegs 2702 cannot be used without the plate 2701, and therefore cannot be entirely received in the bone.
Response: the office is of the position that it has been held that arguments presented by applicant cannot take the place of factually supported objective evidence. See, e.g., In re Schulze, 346 F.2d 600, 602, 145 USPQ 716, 718 (CCPA 1965); In re De Blauwe, 736 F.2d 699, 705, 222 USPQ 191, 196 (Fed. Cir. 1984).
In this case, Applicant already stated that the pegs are intended to penetrate bone, and Chi discloses in ¶148 that pegs 2702 are matched to the distal drill holes 1206. Accordingly, a PHOSITA considering the entirety of Chi would understand that pegs 2702 exhibits at least a portion configured to be entirely received in a cavity of the bone, as required by the claims.
Applicant argues: the proposed combination of Chi and Trabish change the principle of operation of the prior art invention. It takes a surface mounted plate and peg alignment fixture and attempts to convert it into implanted electronic bone anchor device, thereby destroying the principle of Chi, namely to have a plate 2701 on a surface of the bone.
Response: the office is of the position that Chi discloses the elements required by the claim, in this case, Chi discloses pegs 2702 having at least portion intended to be entirely received in a cavity of a bone. The fact the Chi discloses additional components connected to the pegs, i.e. fixture 3909 or 2701 are irrelevant. Moreover, in no where did the office recommended destroying the plate of Chi, all what the office recommended is having the pegs to include built-in IMU in view of Trabish, which is respectfully asserted to not destroy Chi invention, wherein the result of the modification would be a plate with pegs having built-in IMU.
Applicant argues: Chi already solve the tracking problem through it own means, a PHOSITA have no reason to abandon Chi’s proven tracking approach in favor of embedding sensors within pegs.
Response: the office is of the position that "The test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference.... Rather, the test is what the combined teachings of those references would have suggested to those of ordinary skill in the art." In re Keller, 642 F.2d 413, 425, 208 USPQ 871, 881 (CCPA 1981). See also In re Sneed, 710 F.2d 1544, 1550, 218 USPQ 385, 389 (Fed. Cir. 1983) ("[I]t is not necessary that the inventions of the references be physically combinable to render obvious the invention under review."); and In re Nievelt, 482 F.2d 965, 179 USPQ 224, 226 (CCPA 1973) ("Combining the teachings of references does not involve an ability to combine their specific structures."). Moreover, "A person of ordinary skill in the art is also a person of ordinary creativity, not an automaton." KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 421, 82 USPQ2d 1385, 1397 (2007). "[I]n many cases a person of ordinary skill will be able to fit the teachings of multiple patents together like pieces of a puzzle." Id. at 420, 82 USPQ2d 1397. Office personnel may also take into account "the inferences and creative steps that a person of ordinary skill in the art would employ." Id. at 418, 82 USPQ2d at 1396.
In this case, though Chi teaches tracking bone movement by markers 1204, 1210 and 1211, Fig.12 and tracking the robot movement by marker 1203. Chi does not disclose tracking movement and position of the pegs relative to a subject. Accordingly, a PHOSITA would have been motivated to combine the teachings to track the pegs movement and position relative to a subject.
In view of the preceding explanation, the rejections are deemed proper and hereby maintained.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claims 1 – 15 are rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101).
In claim 1, the recitation of “whereby the bone anchor device is an implanted electronic device entirely within the cavity of the bone”, is understood as if the Applicant is claiming “the bone anchor is implanted entirely within the cavity of the bone”, which would encompass the human organism within its scope. Applicant may consider amending the claim to read as “whereby the bone anchor device is an implanted electronic device configured to be implanted entirely within the cavity of the bone”, to overcome this rejection.
Claim Rejections - 35 USC § 103
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.
Claim(s) 1 – 3, 6 – 13, 15 and 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chi (US Pub. 2021/0137613 A) in view of Trabish et al. (US Pub. 2020/0405239 A1).
Claim 1, Chi discloses an on-bone robotic system [abstract, Figs. 1 – 45] comprising:
a bone anchor device configured to be received in a cavity of a bone [Fixture 3909 defines a plate mounted to femur of Fig.39 is described in Fig.27, wherein pegs 2702 are intended to secure the plate 2701 of the fixture to the femur, at least a portion of the pegs defines the claimed bone anchor device with the plate directly extending therefrom or mounted thereon], wherein the bone anchor device is an implanted device configured to be implanted entirely within the cavity of the bone [¶148 of Chi, which in part states “two perpendicular pegs 2702 that are matched to the distal drill holes 1206”, at least a portion of the pegs configured to be implanted entirely within the cavity of the bone is hereby interpreted as corresponding to the claimed anchor];
a robotic tool unit [3901 or 2901] releasably connected directly to the bone anchor device with a releasable connection for the robotic tool unit to be releasable from the bone anchor device [the locking mechanism 2703, which defines a direct connection to the anchor, defines a releasable connection for receiving bar 2704 of the robotic tool unit therethough, Fig.27 and ¶148, or alternatively, ¶150, wherein the robot is detachable from structure 2902 and 2903], the robotic tool unit including at least one actuator for displacing a surgical implement of the robotic tool unit relative to the bone when the robotic tool unit is connected to the bone anchor device when the bone anchor device is implanted [wherein the robotic tool unit has at least one actuator, i.e. activators, ¶13 having servo motors, claim 6, for displacing surgical implement, i.e. 3906, Fig. 39 or the implement connected to 2903, Fig.29A, wherein the implement is a cutting / resection guide / jig, ¶94, ¶167 and claims 14 – 15. Note: the implement is not positive recitation of the claimed system];
wherein the on-bone robotic system includes at least one joint [by at least one of 2902, 2903, 2904, 2905 and 2906] enabling at least one degree of freedom of movement of the surgical implement relative to the bone anchor device [¶150]; and
wherein the on-bone robotic system includes a processor for operating the at least one actuator as a function of the tracking of the bone by the sensor [¶13, ¶76 - ¶77 and ¶145, processing device and non-transitory computer-readable medium encoded with instructions].
Chi discloses the preceding limitations except for disclosing wherein the bone anchor device including at least one sensor for tracking an orientation of the bone, the at least one sensor configured to be inside the bone, whereby the bone anchor device is an implanted electronic device.
Trabish teaches an analogous system [abstract, Figs. 1 – 9] comprising a bone anchor device [262 or 264, or 274 or 276] configured to be entirely received in a cavity of the bone [Figs. 8 – 9], the bone anchor device including at least one sensor for tracking an orientation of the bone [¶113 - ¶116], the at least one sensor being inside the bone, whereby the bone anchor device is an implanted electronic device [¶113 - ¶116 and Figs. 8 – 9, wherein the IMU is within each screw].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the current application to combine the teachings of Chi and Trabish, and substitute the bone anchor device with built-in IMU of Trabish for the pegs of Chi, or alternatively, construct the portions of the pegs of Chi intended for entire implantation within the cavity of the bone to include built-in IMU in view of Trabish . One would have been motivated to do to allow the user tracking movement and position of the bone anchor device relative to a subject, i.e. bone [Trabish, ¶113].
The combination of Chi and Trabish discloses the limitations of claim 1, as above, and further, Trabish discloses:
Claim 2, wherein the bone anchor device has a receptacle configured to be received in the bone, the receptacle accommodating the at least one sensor [¶113, wherein the IMU is housed within each of screws 262 and 264, in a similar manner to measurement system 130].
Claim 3, wherein a leading end of the bone anchor is flared [Figs. 8 – 9, wherein a distal end, defining a leading end of the anchor, is flared].
Claim 6, wherein the at least one sensor includes an inertial sensor [¶113].
Claim 7, wherein the bone anchor device includes a battery [¶119].
Claim 8, wherein the bone anchor device is configured to be used as an implant to track movement of the bone post-operatively [¶113 - ¶116].
The combination of Chi and Trabish discloses the limitations of claim 1, as above, and further, Chi discloses:
Claim 9, wherein the at least one actuator includes at least one motor [wherein the robotic tool unit has at least one actuator, i.e. activators, ¶13 having servo motors, claim 6].
Claim 10, wherein the at least one motor includes two motors [plurality of activators having servo motors, claim 6 and ¶13], the robotic tool unit displacing the surgical implement in at least two rotational degrees of freedom [about at least two of joints 2902, 2903 and 2904, ¶150].
Claim 11, wherein the at least one actuator includes at least one linear actuator [at least one of 2905 and 2906, ¶150].
Claim 12, wherein the surgical implement has a cut slot [Figs. 29].
Claim 13, wherein the robotic tool unit includes at least one sensor for tracking an orientation of the surgical implement [¶75 - ¶78, inertial sensors provided with the bone mounted robotic system].
Claim 15, including a communication device connected to the processor and configured for wireless communication [¶145 - ¶148, wireless transceiver].
Claim 21, Chi discloses an on-bone robotic system [abstract, Figs. 1 – 45] comprising:
a portion configured to penetrate a bone and be used as an implant and another portion connected directly to the implant and configured to project out of the bone [Fixture 3909 defines a plate mounted to femur of Fig.39 is described in Fig.27, wherein pegs 2702, defining at least a portion to penetrate bone, and intended to secure the plate 2701 to the femur, and another components i.e. 2901 or 3901, defining a portion out of the bone, intended to directly connect to the implant by 2704];
the portion configured to penetrate the bone being a bone anchor device configured to be entirely received in a cavity of a bone and remain in the cavity of the bone post-surgery as an implanted electronic device [at least portion of pegs 2702 intended to be entirely received within the cavity of the bone, defines a bone anchor device with the plate 2701 directly extending therefrom or mounted thereon, and exhibits substantially identical structure to the claimed portion, and therefore inherently capable of performing the claimed function(s) if one desire to do so],
the other portion being a robotic tool unit [wherein at least a portion of 3901 or 2901 defines a robotic tool unit] releasably connected directly to the bone anchor device with a releasable connection for the robotic tool unit releasable from the bone anchor device [the locking mechanism 2703, defines a releasable connection for receiving bar 2704 of the robotic tool unit therethough, Fig.27 and ¶148, or alternatively, ¶150, wherein the robot is detachable from structure 2902 and 2903], the robotic tool unit including at least one actuator for displacing a surgical implement of the robotic tool unit relative to the bone intra-operatively when the robotic tool unit is connected to the bone anchor device when the bone anchor device is implanted [wherein the robotic tool unit has at least one actuator, i.e. activators, ¶13 having servo motors, claim 6, for displacing surgical implement, i.e. 3906, Fig. 39 or the implement connected to 2903, Fig.29A, wherein the implement is a cutting / resection guide / jig, ¶94, ¶167 and claims 14 – 15. Note: the implement is not positive recitation of the claimed system];
wherein the on-bone robotic system includes at least one joint [by at least one of 2902, 2903, 2904, 2905 and 2906] enabling at least one degree of freedom of movement of the surgical implement relative to the bone anchor device [¶150];
wherein the on-bone robotic system includes the releasable connection directly between the bone anchor device and the robotic tool unit [27 – 29]; and
wherein the on-bone robotic system includes a processor for operating the at least one actuator as a function of the tracking of the bone by the sensor [¶13, ¶76 - ¶77 and ¶145, processing device and non-transitory computer-readable medium encoded with instructions].
Chi discloses the preceding limitations except for disclosing wherein the bone anchor device including at least one sensor for tracking an orientation of the bone, the at least one sensor configured to be inside the bone, whereby the bone anchor device is an implanted electronic device.
Trabish teaches an analogous system [abstract, Figs. 1 – 9] comprising a bone anchor device [262 or 264, or 274 or 276] configured to be entirely received in a cavity of the bone and remain in the cavity post-surgery [Figs. 8 – 9], the bone anchor device including at least one sensor for tracking an orientation of the bone [¶113 - ¶116], the at least one sensor being inside the bone, whereby the bone anchor device is an implanted electronic device [¶113 - ¶116 and Figs. 8 – 9, wherein the IMU is within each screw].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the current application to combine the teachings of Chi and Trabish, and substitute the bone anchor device with built-in IMU of Trabish for the pegs of Chi, or alternatively, construct the portions of the pegs of Chi intended for entire implantation within the cavity of the bone to include built-in IMU in view of Trabish . One would have been motivated to do to allow the user tracking movement and position of the bone anchor device relative to a subject, i.e. bone [Trabish, ¶113].
Claim(s) 4 – 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chi (US Pub. 2021/0137613 A) in view of Trabish et al. (US Pub. 2020/0405239 A1), as above, and further, in view of Mehl et al. (US Pub. 2019/0388131 A1),Whipple (US Pub. 2006/0217717 A1), or Vitale et al. (US Pub. 2018/0153697 A1).
Claims 4 – 5, the combination of Chi and Trabish discloses the limitations of claim 2, as above.
The combination of Chi and Trabish does not disclose wherein an anti-rotation feature projects laterally from the receptacle; and wherein the anti-rotation feature includes at least one fin.
Mehl teaches an analogous system [abstract, Figs. 1 – 4] comprising a bone anchor device [50] having an anti- rotation feature projects laterally from the receptacle [fins 20 project laterally from a body portion 14 of the anchor device 50, defining receptacle 18]; and wherein the anti-rotation feature includes at least one fin [¶49].
Whipple teaches an analogous system [abstract, Figs. 1 – 30] comprising a bone anchor device [10] having an anti- rotation feature projects laterally from the receptacle [fins 21 project laterally from a body portion of the anchor device 10]; and wherein the anti-rotation feature includes at least one fin [¶15 - ¶17].
Vitale teaches an analogous system [abstract, Figs. 5 – 6] comprising a bone anchor device having an anti- rotation feature projects laterally from the receptacle [fins 224 project laterally from a body portion of the anchor device , ¶45]; and wherein the anti-rotation feature includes at least one fin [Fig.6].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the current application to combine the teachings of Chi, Trabish and Mehl, Whipple or Vitale and construct the anchor device of the combination of Chi and Trabish having anti-rotation fins in view of Mehl, Whipple or Vitale. One would have been motivated to do so in order to provide the anchor device of the combination of Chi and Trabish with a configuration that resist rotation of the implant once fully seated into the bone [¶49, Mehl].
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chi (US Pub. 2021/0137613 A) in view of Trabish et al. (US Pub. 2020/0405239 A1), as above, and further, in view of Dees, Jr. (US Pub. 2022/0039869 A1).
Claim 14, the combination of Chi and Trabish discloses the limitations of claim 1, as above, except for explicitly disclosing wherein the robotic tool unit includes at least one camera oriented toward the bone and configured to capture images of the bone.
Dees teaches an analogous system comprising a robotic tool unit including at least one camera oriented toward the bone and configured to capture images of the bone [¶64, camera mounted on robotic arm].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the current application to combine the teachings of Chi, Trabish and Dees, and construct the robotic tool unit of the combination of Chi and Trabish having camera in view of Dees. One would have been motivated to do so in order to provide the robotic tool unit of the combination of Chi and Trabish with a tacking system that allow tracking surgical objects and patient anatomy in the surgical theatre.
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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/SAMUEL S HANNA/Primary Examiner, Art Unit 3775
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