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 Objections
Claims 137-140 objected to because of the following informalities:
In claim 137, at line 4, “lateral-facing” should read ---laterally facing---
In claim 138, at line 1, “lateral-facing” should read ---laterally facing---
In claim 139, at line 1, “lateral-facing” should read ---laterally facing---
In claim 140, at line 1, “lateral-facing” should read ---laterally facing---
Appropriate correction is required.
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 144-145 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.
Claim 144 recites the limitation "the second recesses" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim. Examiner notes that claim 145 currently depends from claim 143, and claim 132 recites each arm of the receiver member comprising “a second recess formed in the outer surface of the receiver member at a position distal to the first recesses”. For examination purposes, claim 143 will be interpreted as depending from claim 132 in order to provide proper antecedent basis for the limitation “the second recesses” in claim 144.
Claim 145 is rejected due to dependency on claim 144.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 130-131, 136, 141, 147 and 148 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Donahue (US 2013/0060294 A1).
Regarding claim 130, Donahue teaches a bone anchor assembly (100; Figs. 1A-1C; para. 0036), comprising:
a bone anchor (114; Fig. 1A-1D; para. 0045) having a proximal head portion (114p; Fig. 1D) and a distal threaded bone-engaging portion (114d; Fig. 1D);
a receiver member (112; Figs. 1A-1D; para. 0037) having a proximal end (112p; Fig. 1A) defined by a pair of spaced apart arms (116a, 116b; Fig. 1A) forming a U-shaped recess (117; Fig. 1A) configured to receive a spinal fixation element therebetween (for receiving a spinal fixation element, such as a rod, as described in at least para. 0037) and a distal end (112d; Fig. 1A) having a polyaxial seat formed therein for polyaxially seating the head portion of the bone anchor (para. 0038 describes distal end 112b as having a concave cavity formed therein that seats a portion of bone anchor 114, i.e. proximal head portion 114p as shown; Figs. 1A-1D; also see para. 0046);
wherein a first pair of the opposing laterally-facing sides (defined by first lateral sides of arms 116, i.e. left and right sides as viewed in Fig. 1B) of the receiver member has a first taper with respect to a first plane that contains a proximal-distal axis of the receiver member (see Fig. 1B, showing a first plane as viewed in the page and containing proximal-distal axis Z, where the opposing left and right sides have a first taper defined by angle alpha; para. 0039),
wherein a second pair of the opposing laterally-facing sides (defined by second lateral sides of arms 116, i.e. left and right sides as viewed in Fig. 1C) of the receiver member has a second taper with respect to a second plane that contains the proximal-distal axis and is offset from the first plane (see Fig. 1C, showing a second plane as viewed in the page and containing the proximal-distal axis Z identified in Fig. 1B, where the opposing left and right lateral sides taper from a width x2 to a narrower width x1 toward the proximal end of the receiver member, the second plane shown in Fig. 1C being orthogonal to the first plane shown in Fig. 1B; para. 0040), and
wherein the first taper and the second taper each extend to a proximal-most end of the receiver member (as shown, the first taper at angle alpha in Fib. 1B extends to the proximal-most end of receiver 112, and the second taper, i.e. defined by narrowed section having width x1, also extends to the proximal-most end).
Regarding claim 131, Donahue discloses the assembly of claim 130, wherein the first plane is perpendicular to the second plane (as described above, the first plane viewed in the page of Fig. 1B and extending through the central longitudinal axis Z is perpendicular to the second plane viewed in the page of Fig. 1C).
Regarding claim 136, Donahue discloses the assembly of claim 130, wherein the U-shaped recess is configured to receive a spinal fixation element of various sizes (U-shaped recess 117 is capable for receiving a spinal fixation element of various sizes; Fig. 1A).
Regarding claim 141, Donahue discloses the assembly of claim 130, wherein the proximal ends of the spaced apart arms (116a, 116b; Figs. 1A, 1F) lie along a common circular circumferential path (as shown in Fig. 1F).
Regarding claim 147, Donahue discloses the assembly of claim 130, wherein the bone anchor includes a bore extending proximally from a distal tip of the bone engaging portion (para. 0045 teaches that the bone anchor 114 may be cannulated, i.e. having a bore extending therethrough).
Regarding claim 148, Donahue discloses the assembly of claim 147, wherein the bore extends through an entire length of the bone anchor (para. 0045 teaches that the bone anchor 114 may be cannulated, i.e. having a bore extending therethrough).
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.
Claims 132-135 and 143-145 are rejected under 35 U.S.C. 103 as being unpatentable over Donahue (US 2013/0060294 A1), as applied to claim 130 above, further in view of Corin (US 2013/0144349 A1) and in view of Gerchow (US 2012/0310284 A1).
Regarding claim 132 and 133, Donahue discloses the assembly of claim 130, wherein the receiver member further comprises a groove (118a, 118b; Fig. 1A) formed in an outer surface of each of the spaced apart arms at a proximal end thereof (as shown; Figs. 1A-1C; para. 0043).
Donahue does not disclose [Claim 132] a first recess formed in the outer surface of each arm with at least a portion of the first recess intersecting the groove, and a second recess formed in an outer surface of the receiver member at a position distal to the first recesses; wherein the first recesses and the second recesses are configured to couple to a surgical instrument; [Claim 133] wherein at least a portion of the first recess in each arm extends proximally beyond the groove.
Corin is considered analogous to the claimed invention because it is directed towards a bone anchor assembly with a receiver member (see assembly 100 with receiver 104 in Fig. 1; para. 0013), and teaches wherein the receiver member (104; Fig. 2) includes a groove (112; Figs. 1-2) formed in an outer surface of each of the spaced apart arms at a proximal end thereof (first mating surfaces/grooves 112 provided on spaced apart arms of receiver member, as shown on one arm in Fig. 2; para. 0013-0014); and wherein the receiver member includes first recess (112a; Figs. 1-2) formed in an outer surface of each arm (as shown on one arm in the view of Fig. 2) with at least a portion of the first recess intersecting the first groove (lower portion of dimple/recess 112a intersects groove 112; Fig. 2), wherein the first recesses are configured to couple to a surgical instrument (recesses 112a are capable of coupling with a surgical instrument; Fig. 2; para. 0013), wherein at least a portion of the first recess in each arm extends proximally beyond the groove (as shown in Figs. 1-2, a part of recess 112a extends proximally beyond groove 112).
Gerchow is considered analogous to the claimed invention because it is directed towards a bone anchor assembly with a receiver member (shown in at least Figs. 1A-B and 4A-B, with receiver member/cup 8; para. 0047), and teaches wherein the receiver member includes a “second recess”, i.e. lower recess (48/50; Figs. 1A-B) formed in an outer surface of the receiver member (as shown in Figs. 1A-B and 4A-B); wherein the second recess is configured to couple to a surgical instrument (a tool can be inserted into recesses 48/50 so as to punch the sidewall in to hold an inner saddle 10 in place within the receiver member/cup 8; Figs. 1A-4B; para. 0058).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Donahue’s receiver member to include both Corin’s first recess, intersecting and extending upward from each of Donahue’s groove at the proximal portion of the receiver member (i.e., so that a portion the first recesses extend proximally beyond the grooves, as shown in Figs. 1-2 of Corin) and to further include Gerchow’s second recesses formed on each receiver arm, at a position distal to the first recesses as claimed, because each of these tool engagement features are known in the art for allowing a user to manipulate the receiver member during installation of the bone anchor assembly. Specifically, Corin recognizes that the configuration of the groove with an upwardly extending recess can be engaged by a tool to facilitate implanting of the assembly (see Corin’s tool 600 for engaging groove 112 and recess 112a; Figs. 1-2, 4; para. 0013, 0019), while Gerchow teaches the second recesses cooperating with a compression member so that a tool can engage the second recess to deform the wall of the receiver inward to maintain the position of the compression member to prevent proximal movement of a bone anchor positioned within the receiver (see Gerchow, Figs. 1A-B and 4A-B, para. 0050), so the inclusion of both of these features with Donahue’s receiver member so as to provide the claimed first and second recesses would involve only routine experimentation in the art and enable better gripping and/or manipulation of the receiver member.
Regarding claim 134, the combined disclosures of Donahue, Corin and Gerchow teach the assembly of claim 132, wherein each of the second recesses is longitudinally aligned with one of the first recesses (where Donahue’s receiver member has been modified to include Corin’s first recesses and Gerchow’s second, more distal recesses, each of the first and second recesses are located at the middle of a respective receiver arm and are aligned; see Corin’s first recesses 112a in Figs. 1-2 and Gerchow’s recesses 48, 50 in Figs. 1A-1B).
Regarding claim 135, the combined disclosures of Donahue, Corin and Gerchow teach the assembly of claim 132, wherein the first recesses are configured to pivotably couple to a surgical instrument and the pair of second recesses are configured to pivotably couple to a surgical instrument (where Donahue’s receiver member has been modified to include Corin’s first recesses and Gerchow’s second, more distal recesses, Corin’s first recesses 112a in Figs. 1-2 are formed as dimples or detents acting as alignment features and are capable of pivotably coupling to a surgical instrument, as described in para. 0013 of Corin, and Gerchow’s recess 48, 50 shown in Figs. 1A-B and 4A-B are also capable of pivotably coupling with a surgical instrument, as described in para. 0050 of Gerchow).
Claims 137-140 are rejected under 35 U.S.C. 103 as being unpatentable over Donahue (US 2013/0060294 A1), as applied to claim 130 above, further in view of Steib (US 2013/0238030 A1).
Regarding claim 137, Donahue teaches the assembly of claim 130.
Donahue does not specifically disclose wherein each spaced apart arm has a laterally-facing recessed portion formed on opposite lateral edges of the arm, each of the lateral-facing recessed portions facing away from a central proximal-distal axis of the receiver member, wherein the lateral-facing recessed portions are configured to engage with a surgical instrument such that the U-shaped recess remains unobstructed.
Steib is considered analogous to the claimed invention because it is directed to a bone anchor assembly with a receiver member (see bone anchor system 100, with receiver member/head 110; Figs. 5-7; para. 0024), and teaches wherein each spaced apart arm has a laterally-facing recessed portion formed on opposite lateral edges of the arm (each arm 144 of receiver 110 includes two laterally-facing recessed channels 146 formed on opposite lateral edges, for accommodating end members 114 of a cross-link member 104; Figs. 6-7; para. 0028), each of the laterally-facing recessed portions facing away from the central proximal-distal axis of the receiver member (recessed portions 146 shown formed on an external surface at lateral sides of each arm 144, thus opening facing away from a central axis extending through the receiver 110; Fig. 6), wherein the laterally-facing recessed portions are configured to engage with a surgical instrument such that the U-shaped recess remains unobstructed (as shown in Fig. 7, recessed portions 146 on the left arm can be engaged by an end member 114, and therefore can be engaged by a surgical instrument, so that the U-shaped recess 140 for receiving rod 106 remains unobstructed; Figs. 6-7; para. 0027-0028).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Donahue’s receiver member to include Steib’s laterally-facing recessed portions formed on opposite lateral edges of each arm, as described above, because Steib teaches wherein these recessed edge portions can provide an attachment feature that could be engaged by various tools to accommodate manipulation/placement of the receiver member during implantation of the bone anchor assembly (see Steib, Figs. 6-7, para. 0028-0029).
Regarding claim 138, Donahue and Steib disclose the assembly of claim 137, and Steib teaches wherein each of the lateral-facing recessed portions extend distally from the proximal end of the spaced apart arms (shown in Fig. 6, each laterally-facing recessed portion 146 extends distally from proximal end 148 of arms 144; para. 0028).
Regarding claim 139, Donahue and Steib disclose the assembly of claim 137, and Steib teaches wherein each laterally-facing recessed portion has a concave distal surface (each recessed portion 146 includes a dimple attachment feature 150 at a lower end defining a concave distal surface; Fig. 6; para. 0028).
Regarding claim 140, Donahue and Steib disclose the assembly of claim 139, and Steib teaches wherein each laterally-facing recessed portion (146; Fig. 6) has a first planar surface, a second planar surface substantially perpendicular to the first planar surface, and a curved surface therebetween (see Examiner’s Annotated Fig. 6 of Steib below).wherein each lateral-facing recessed portion has a first planar surface, a second planar surface substantially perpendicular to the first planar surface, and a curved surface therebetween.
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Examiner’s Annotated Fig. 6 of Steib
Claim 142 is rejected under 35 U.S.C. 103 as being unpatentable over Donahue (US 2013/0060294 A1), as applied to claim 130 above, further in view of Ramsay (US 2018/0325569 A1).
Regarding claim 142, Donahue teaches the assembly of claim 130.
Donahue does not disclose the assembly further comprising a drag ring disposed within the receiver member, the drag ring configured to exert a friction force on the head portion of the bone anchor.
Ramsay, in analogous art, discloses a bone anchor assembly (200; Fig. 2A; para. 0076) comprising a bone anchor (202; Figs. 2A, 2F; para. 0076) and a receiver member (204; Fig. 2A; para. 0076) having a pair of spaced apart arms (214A, 214B; Fig. 2A; para. 0076) and a distal end having a polyaxial seat formed therein for polyaxially seating the locking sphere (lower end of receiver member 204 has a spherical interior surface defining a polyaxial seat that engages corresponding spherical exterior surface of locking sphere 230; Fig. 2A; para. 0077), and a drag ring (232; Figs. 2A, 2E; para. 0078) disposed within the receiver member (204, as shown; Fig. 2A) and configured to exert a friction force on the locking sphere (drag ring 232 exerts frictional drag force against locking sphere 230; Fig. 2A; para. 0078).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Donahue’s assembly to include a drag ring disposed in the receiver member as taught by Ramsay, i.e. disposed about the head of the bone anchor, because Ramsay recognizes that providing a drag ring in the claimed manner supplies a drag force, exerting a frictional drag force against the bone anchor head to resist polyaxial motion between the anchor and the receiver member (see Ramsay, para. 0078).
Claims 143-145 are rejected under 35 U.S.C. 103 as being unpatentable over Donahue (US 2013/0060294 A1), Corin (US 2013/0144349 A1) and Gerchow (US 2012/0310284 A1), as applied to claim 132 above, further in view of Biedermann (US 2016/0331412 A1).
*Note that claim 143 is interpreted as depending from claim 132 in order to provide proper antecedent basis, as described above in the rejection of claim 144 under 35 U.S.C. 112(b).
Regarding claim 143 (*as best understood), the combined disclosures of Donahue, Corin and Gerchow teach the assembly of claim *132, and Donahue discloses the assembly further comprising a compression member disposed within the receiver member.
Neither Donahue nor the other references cited in the combination above disclose wherein a proximal portion of the compression member includes opposing planar surfaces that are angularly offset from one another forming a seat for receiving a spinal fixation element.
Biedermann, in analogous art (see Figs. 1-2), discloses wherein a proximal portion of a compression member (proximal portion 61 of compression member 6; Figs. 1-2, 7, 10) includes opposing planar surfaces that are angularly offset from one another forming a seat for receiving a spinal fixation element (para. 0076, with reference to Figs. 7-10, describe the proximal portion having a rod support surface 62 having a V-shape, i.e. having opposing planar surfaces that are angularly offset from one another).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the proximal rod seating surface of Donahue’s compression member to have Biedermann’s V-shaped profile, thus having the claimed configuration, because Biedermann teaches that such a shape permits the compression member to support rods of different diameters because inserted rods to be supported contact the rod contact surface with at least two contact lines (see Biedermann, para. 0076).
Regarding claims 144 and 145, the combined disclosures of Donahue, Corin, Gerchow and Biedermann teach the assembly of claim 143, and Gerchow discloses [Claim 144] wherein material displaced in the formation of the second recesses is configured to restrict movement of the compression member relative to the receiver member (a tool can be inserted into “second” recess 48/50, i.e. coupled therewith, to deform/displace the sidewall of receiver member/cup 8 into a corresponding detent in a compression member to lock assembly; Figs. 1A-4B; para. 0058), and [Claim 145] wherein the displaced material is received within corresponding recesses formed in the compression member (as shown between Figs. 1A-5B and described in para. 0058-0060).
Claim 146 is rejected under 35 U.S.C. 103 as being unpatentable over Donahue (US 2013/0060294 A1), as applied to claim 130 above, further in view of Jackson (US 2019/0150990 A1).
Regarding claim 146, Donahue discloses the assembly of claim 130, further comprising a fixation element configured to be received between the spaced apart arms of the receiver member (see set screw 180 shown in Fig. 1F, described in para. 0049 as a fixation element received between arms 116a, 116b).
Donahue does not specifically disclose the fixation element having external square threads configured to be received between the spaced apart arms of the receiver member.
Jackson is considered analogous to the claimed invention because it is directed towards a bone anchor assembly (bone screw assembly 1; Fig. 1; para. 0259) with a receiver member (10; Fig. 1) having a pair of spaced apart arms (82’, 82’’; Fig. 1; para. 0280) and fixation element (18; Figs. 1-2) received therein (as shown in Fig. 2; para. 0259-0260), and teaches wherein the fixation element includes external square threads (78; Figs. 1-2; para. 0311) configured to be received between the spaced apart arms of the receiver member (fixation element/closure 18 includes an external square thread structure 78 mating with interior square thread structure 92 on each of the pair of arms 82’, 82’’ so that the fixation element 18 is received between the arms of the receiver member 10; Figs. 1-2; para. 0281, 0311).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the external threads of Donahue’s fixation element to be square threads, as taught by Jackson, because Jackson recognizes square threads as a suitable alternative for a fixation element to be received between spaced apart arms of a receiver member in a bone anchor assembly (see Jackson, Figs. 1-2).
Claim 149 is rejected under 35 U.S.C. 103 as being unpatentable over Donahue (US 2013/0060294 A1), as applied to claim 147 above, further in view of Reed (US 2014/0257409 A1).
Regarding claim 149, Donahue discloses the assembly of claim 147.
Donahue also discloses wherein the bone anchor may be cannulated or non-cannulated (see para. 0045), but does not disclose wherein the bore is a blind bore.
Reed is considered analogous to the claimed invention because it is directed towards a threaded bone anchor (10; Fig. 8; para. 0055) for wherein the bone anchor includes a bore (16; Fig. 8) extending proximally from a distal tip of the bone engaging portion (bore 16 extends proximally towards head 2 from distal tip 7 of the bone engaging portion of anchor 10 having thread 12; Fig. 8; para. 0055), and wherein the bore (16; Fig. 8) is a blind bore (as shown in Fig. 8, bore 16 is a blind bore open at a distal end 7 of the bone anchor 10 and closed at a proximal end; para. 0055).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Donahue’s bone anchor to include Reed’s bore section extending proximally from a distal end of the threaded bone engaging portion of the anchor, as claimed, because Reed recognizes this as a suitable structure for a bone anchor that provides a bone chip/shard repository at the distal end of the bone anchor that can receive bone fragments as the anchor is implanted, so that fewer bone cuttings are disposed at the interface between the bone and fastener to provide healthier bone tissue adjacent the fastener to prevent additional trauma to the bone” (see Reed, Figs. 1, 8; para. 0011, 0055, 0067).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Other relevant references can be found in the attached PTO-892, including Farris (US 2010/0222822 A1) which teaches a receiver member wherein “outer surfaces 40 have an inward taper 43, which taper allows for easier handling of the [receiver member]” (see Figs. 1-3, para. 0076).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANNA VICTORIA LITTLE whose telephone number is (571)272-6630. The examiner can normally be reached M-F 9a-6p EST.
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, Eduardo Robert can be reached at (571)272-4719. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ANNA V. LITTLE/ Examiner, Art Unit 3773 /EDUARDO C ROBERT/ Supervisory Patent Examiner, Art Unit 3773
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