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 .
Election/Restrictions
Applicant’s election of Group II, claims 12-20, in the reply filed on February 26, 2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)). Claims 1-11 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
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.
Claims 18 and 19 are 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.
Regarding claim 18, “wherein a first bridge interface of the two bridge interfaces and the anchor interface is a ball” and “a second bridge interface of the two bridge interfaces and the anchor interface is a socket” are indefinite, as it is unclear how the “a first bridge interface” or “a second bridge interface” could include an anchor interface. For the purpose of examination, it is assumed at least one bridge interface of the two bridge interfaces is a ball, and the other bridge interface of the two bridge interfaces is a socket.
Regarding claim 19, “the bridge interface” has unclear antecedent basis as two bridge interfaces are recited in claim 12, from which claim 19 depends. For the purpose of examination, it is assumed one bridge interface of the two bridge interfaces is referred to.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 20 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 20 fails to further claim 1, from which it depends, as claim 20 requires at least one anchor to comprise a tracking marker, while claim 1 requires each anchor to comprise a tracking marker.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
Claims 12 and 16-20 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Application Publication No. 2020/0170682 (Boehm) in view of U.S. Patent Application Publication No. 2017/0348061 (Joshi) and U.S. Patent Application Publication No. 2005/0261768 (Trieu).
Regarding claim 12, Boehm discloses a spinal stabilization system (460) comprising: one or more anchors (461//425 and 461a/425a), each anchor comprising: a clamp (461/461a) configured to engage an anatomical element (a vertebral body, see Fig. 6 and Abstract, e.g.), the clamp movable between a fully open position and a fully closed position (via tightening and loosening of locking screw 425/425a, see paragraphs [0069], [0070], and [0174]), the clamp comprising a first arm (422/422a, see Fig. 38 and paragraph [0177]) and a second arm (423/423a, see Fig. 38 and paragraph [0177]) configured to rotate relative to the first arm via a pivot point (axle 424/424a, see Fig. 38 and paragraphs [0174] and [0177]); a locking screw (425/425a) configured to selectively prevent the clamp from being moved into the fully open position (see paragraphs [0069], [0070], and [0174]; screws can be selectively tightened to prevent the clamp from being moved into the fully open position); a head (ends of 426/426a including axles 424/424a, similar to ends 11/13 coupled by axle 72 in Fig. 5); two bridge interfaces (476/481) adjacent to each other (end of 481 with securing screw 489 is adjacent end of 481 with securing screw 490); at least one bridge receptacle (483); and at least one bridge (485, 486, or an accessory connecting rod, see paragraph [0178]) comprising a rigid member (485, 486, or an accessory connecting rod, see paragraph [0178]) having a first end (487, 488, or one end of the accessory connecting rod, see paragraph [0178]) and a second end (492, 493, or the other end of the accessory connecting rod, see paragraph [0178]) opposite the first end, each of the first end and the second end comprising an anchor interface (see paragraph [0178] and Fig. 41), wherein the two bridge interfaces are configured to receive the anchor interface (see paragraph [0178]).
Further regarding claim 12, Boehm fails to disclose the head having the two bridge interfaces. However Boehm discloses a spinal stabilization system anchor (421, see Fig. 38), wherein the anchor includes a head (articulating ends of 422/423 coupled by axle 424) having a bridge interface (431/432/433). It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the invention to modify the anchors (461a-z) of Boehm by relocating the two bridge interfaces (476/481) to the head of the of the anchor because shifting the position of the two bridge interfaces would not have modified operation of the spinal stabilization system and would have been an obvious matter of design choice, as suggested by the varying locations of the bridge interfaces on the anchors in different embodiments of Boehm. See In re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950) and In re Kuhle, 526 F.2d 553, 188 USPQ 7 (CCPA 1975).
Further regarding claim 12 and regarding claim 20, Boehm fails to disclose each anchor comprising a tracking marker (claim 12); wherein at least one anchor of the one or more anchors comprises tracking marker (claim 20). However, Joshi discloses a bone anchor (6300) comprising a tracking marker (690/720) (see paragraph [0218]). It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the invention for each anchor of Boehm to include a tracking marker as suggested by Joshi in order to facilitate navigation of a surgical robot for use in robot-assisted surgery (see Abstract and paragraph [0081]).
Further regarding claim 12 and regarding claim 16, Boehm fails to disclose wherein each anchor further comprises a spring at the pivot point (claim 12); wherein the spring of each of the one or more anchors is configured to bias the clamp toward the fully closed position (claim 16). However, Trieu discloses a vertebral bone anchor (40) that comprises a spring (48) at a pivot point (47) about which arms (41-44) of the anchor pivot (see paragraph [0052]); wherein the spring is configured to bias the arms toward a closed position (see paragraph [0052]). It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the invention to modify the clamps of the anchors of Boehm to comprise a spring at a pivot point in order to facilitate securing of the clamps to bone by biasing the clamp to the closed position in which the clamp grips bone (see Trieu, paragraph [0052]), thus requiring more force to open the clamp and detach it from bone.
Regarding claim 17, Boehm discloses wherein the clamp comprises: a first contact surface (15) opposite and facing a second contact surface (14) (see Figs. 5 and 41); and a plurality of teeth (21/22) on at least one of the first contact surface and the second contact surface (see Figs. 5 and 41), the plurality of teeth configured to prevent movement of the clamp relative to the anatomical element when the clamp is engaged with the anatomical element (see paragraph [0107]).
Regarding claim 18, embodiment 460a of Boehm fails to disclose wherein a first bridge interface of the two bridge interfaces and the anchor interface is a ball, and a second bridge interface of the two bridge interfaces and the anchor interface is a socket. However, Boehm discloses an anchor embodiment (see Fig. 39A) having two bridge interfaces (441/442), wherein one of the bridge interfaces is an extension (455), and the other bridge interface is a socket (454). It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the invention to have the two bridge interfaces comprise an extension and a socket instead of two sockets, as it would be an obvious matter of design choice that does not affect the operation of the device for the two bridge interfaces to have any combination of sockets and extensions.
Further regarding claim 18, additionally, embodiment 520 of Boehm discloses using a ball (526) and socket (523) interfaces. It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the invention to modify at least one bridge interface of Boehm to have a ball as suggested by Boehm in order to confer polyaxial movement of the bridge/anchor interfaces, which helps accommodate slight variances in the alignment of the coupled anchors from level to level (see Boehm, paragraphs [0085] and [0173]).
Regarding claim 19, Boehm discloses wherein the two bridge interfaces further comprises a lock (489/490) configured to selectively prevent movement of the bridge relative to the anchor when the anchor interface is received by the bridge interface (see paragraph [0178] and Fig. 41).
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Boehm in view of Joshi and Trieu, and further in view of U.S. Patent Application Publication No. 2013/0072979 (Butler).
Regarding claim 13, Boehm discloses wherein the first arm extends from the head to a first foot (end of arm opposite head; similar to portion 12, see Fig. 5) and the second arm extends from the head to a second foot (end of arm opposite head; similar to portion 10, see Fig. 5). Boehm fails to explicitly disclose each of the first foot and the second foot having a planar surface. However, Butler discloses a spinal bone anchor (110) including two arms (112/114), wherein feet (118/134) of the arms have planar surfaces (128/144) (see paragraphs [0070] and [0072]). It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the invention to modify the feet of Boehm to have planar surfaces as suggested by Butler, as Boehm does not require the feet surfaces to be any specific shape, and Butler suggests planar feet surfaces are acceptable for facilitating gripping of a spinal bone by a spinal bone anchor (see Butler, paragraphs [0070] and [0072]). Additionally, Applicant states that a planar shape is one of numerous shapes a foot surface may have (see paragraph [0076] of the present application), and the planar shape has no special significance that would make its choice non-obvious. See In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966).
Claims 14 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Boehm in view of Joshi and Trieu, and further in view of U.S. Patent Application Publication No. 2008/0097441 (Hayes).
Regarding claim 14, Boehm fails to explicitly disclose wherein a first one of the one or more anchors has a first height, and a second one of the one or more anchors has a second height different than the first height. However, Hayes discloses a spinal stabilization system (see Abstract) including clamp anchors (100/100’) which have different heights (see paragraph [0074] and Figs. 7A-7C). It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the invention to modify the system of Boehm to have anchors with different heights to allow the system to attach to differently-sized spinal features (see paragraph [0074]) as needed for a given patient .
Regarding claim 15, it would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the invention to have the anchors within the recited ranges since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). Additionally, Applicant does not state in the present specifications that the recited ranges are critical to proper functioning of the claimed invention (see paragraph [0087] of the specification of the present application), but rather include broad ranges workable for the general conditions of the invention.
Conclusion
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/NICHOLAS J PLIONIS/Primary Examiner, Art Unit 3773