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
The numbering of claims is still not in accordance with 37 CFR 1.126. When new claims are presented, they must be numbered consecutively beginning with the number next following the highest numbered claims previously presented (whether entered or not). Claim 7 is missing from the listing of claims. As stated in the Office action mailed 24 March 2026, claim 7 has been treated as having been canceled by Applicant to facilitate examination. However, Applicant is required to correct the claim numbering in the next reply.
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 1-6 and 8-18 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.
In independent claim 1, the language “and adapted to be attached to only a rod member and not to any bone fastener” conflicts with the claim, which requires the first tulip element and the second tulip element to be a unitary body. As such, the second tulip element is necessarily attached to the claimed bone fastener. As best understood and for purposes of examination, this language will be treated as reciting “and not directly over any bone fastener.”
In independent claim 12, it is unclear what is meant by “by contacting the ring via the saddle.” As best understood and for purposes of examination, this limitation will be treated as reciting “in contact with the ring and the saddle.”
Appropriate correction is required.
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 1, 5, 8-11, 14, 15, 17, 18 and 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Picetti et al. (2004/0111088).
Regarding claim 1, Picetti et al. disclose a method of stabilizing a spine, comprising:
providing a spine stabilizing system (e.g., Fig. 6) including:
a bone fastener 314,
a first tulip assembly comprising a first tulip element (left) having a saddle 370 (i.e., crown; para. 0035) and a ring 366,
a second tulip assembly comprising a second tulip element (right) and adapted to be attached to only a rod member in channel 324 and not directly over any bone fastener (Fig. 6);
a first rod member R configured to be positioned within the saddle 370 of the first tulip assembly (id.),
a second rod member R2 (cf. Fig. 4) configured to be positioned within channel 324 of the second tulip element (right) of the second tulip assembly (Fig. 6);
attaching the first tulip element of the first tulip assembly to the bone fastener 314 (paras. 0034-0036);
inserting the bone fastener 314 into the first tulip element such that the bone fastener contacts the saddle 370 of the first tulip assembly (Fig. 6);
wherein the bone fastener 314 is retained within the first tulip assembly via the ring 366 positioned within a groove on a bottom portion of the first tulip assembly (id.), and
wherein a bottom portion of the second tulip assembly is oblique (e.g., along the curved bottom right portion) relative to the bottom portion of the first tulip assembly (id.),
wherein the first tulip element (left) and the second tulip element (right) are a unitary body (id.).
It is noted that Picetti et al. recognizes that either one or two fasteners can be used effectively and further describes having to form only one hole in bone to fasten the embodiment having a single fastener (see, paras. 0004, 0032, 0034, 0039 and cf., e.g., Figs 6 and 8).
Regarding claim 5, the first tulip assembly is disposed parallel relative to the second tulip assembly (Fig. 6).
Regarding claim 8, the first tulip assembly has tool engagement features (Fig. 6, cf., e.g., 46 and 48 of Figs. 1 and 3 and paras. 0021, 0031 and 0035).
Regarding claim 9, the first tulip assembly and the second tulip assembly has one or more side tool engagement features (Fig. 6, cf., e.g., 46 and 47 of Fig. 3, and paras. 0021, 0031 and 0035).
Regarding claim 10, the first tulip assembly has one or more front or rear tool engagement features (Fig. 6, cf., e.g., 49 of Fig. 1, and paras. 0021, 0031 and 0035) that are on a different face from the one or more side tool engagement features (e.g., cf. 46 of Fig. 3; and paras. 0021, 0031 and 0035).
Regarding claim 11, Picetti et al. disclose a method of stabilizing a spine, comprising:
providing a spine stabilizing system (e.g., Fig. 6) including:
a bone fastener 314,
a first tulip assembly comprising a first tulip element (left) that includes a saddle 370 (i.e., crown; para. 0035), wherein the first tulip assembly is configured to receive a first rod R,
a second tulip assembly comprising at least one tulip element (right) and adapted to be attached to only a rod member R2 (cf. Fig. 4) and not directly to any bone fastener, wherein the at least one tulip element (right) of the second tulip assembly is configured to receive a second rod R2 in channel 324 (Fig. 6);
attaching the first tulip element over the first bone fastener 314 (paras. 0034-0036);
retaining the bone fastener 314 in the first tulip assembly via a ring 366; and
locking the bone fastener 314 into the first tulip assembly in contact with the ring 366 and the saddle 370 (Fig. 6).
Regarding claim 14, the first tulip assembly is parallel relative to second tulip assembly (Fig. 6).
Regarding claim 15, the first tulip assembly includes an opening H (cf. Fig. 5) through a lower surface for receiving the first bone fastener 314 therethrough (Fig. 6) and the second tulip assembly has no opening through a lower surface (id.).
Regarding claim 17, the first tulip assembly includes one or more side tool engagement features (Fig. 6, cf., e.g., 46 of Fig. 3) and the second tulip assembly also includes one or more side tool engagement features (Fig. 6, cf., e.g., 47 of Fig. 3).
Regarding claim 18, the method further comprises downwardly depositing a first and second locking cap assembly, e.g., 44 (Fig. 1; para. 0019) over the first tulip element (left) of the first tulip assembly and the tulip element (right) of the second tulip assembly (id.).
Regarding claim 20, the second tulip element (right) includes a closed bottom to prevent direct attachment over any bone fastener (Fig. 6).
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.
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 2-4, 6, 12, 13 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Picetti et al. (2004/0111088), as applied above, in view of Schafer (DE-9314297-U1; cf. machine translation; both of record).
Regarding claim 2, Picetti et al. disclose the claimed invention except for explicitly reciting a configuration including a bridge that extends between the first tulip element and the second tulip element.
Schafer discloses a stabilizing system (Fig. 1) having two adjacent tulip elements 12 and 13 angled relative to each other via a bridge (Fig. 1) extending between a first tulip element 12 and a second tulip element 13 such that the tulips do not share a wall and each comprise first and second arms 16, 17 and 18, 19, respectively (Fig. 1). This configuration allows both tulips to conform in close contact to the shape of vertebral bone (id. and translation page 3, lines 7-9).
It would have been obvious to a person having ordinary skill in the art before the effective filing date to configure the first tulip element (left) and the second tulip element (right) of Picetti et al. (supra) to be angled relative to each other via a bridge (Fig. 1) extending between the first tulip element and the second tulip element such that the tulips do not share a wall and each comprise first and second arms, in view of Schafer, to allow both tulips to conform in close contact to the shape of vertebral bone.
Regarding claim 3, the spine stabilizing system of the combination (supra) includes wherein the first tulip element of the first tulip assembly includes a first arm and a second arm and the second tulip element of the second tulip assembly includes a first arm and a second arm (supra; cf. Fig. 1 of Schafer).
Regarding claim 4, each of the arms of the first tulip assembly of the combination (supra) are independent from one another such that they do not share a wall (cf. Fig. 1 of Schafer).
Regarding claim 6, the first tulip assembly of the combination (supra) is offset at an angle relative to the second tulip assembly of the combination (cf. Fig. 1 of Schafer).
Regarding claim 12, the spine stabilizing system of the combination (supra) includes wherein the first tulip element of the first tulip assembly includes a first arm and a second arm and the second tulip element of the second tulip assembly includes a first arm and a second arm (supra; cf. Fig. 1 of Schafer).
Regarding claim 13, the first tulip assembly of the combination (supra) is at an angle relative to the second tulip assembly of the combination (cf. Fig. 1 of Schafer).
Regarding claim 16, the first tulip assembly of the combination (supra) includes one or more side tool engagement features (Fig. 6, cf., e.g., 46 of Fig. 3, describing indentations to accommodate a holding or twisting tool), but Picetti et al. do not disclose the second tulip element of the second tulip assembly not including any side tool engagement features.
However, it would have been further obvious to a person having ordinary skill in the art before the effective filing date to not provide any side tool engagement features on the second tulip of the combination (supra), e.g., to reduce manufacturing steps, because the device is unitary and such that holding or twisting functions would be accomplished via a single tulip.
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Picetti et al. (2004/0111088) in view of Schafer (DE-9314297-U1; cf. machine translation; both of record), as applied above, further in view of Jackson (2006/0111712).
The spine stabilizing system of the combination of Picetti et al. and Schafer (supra) discloses the claimed invention including attaching a tool to the tulip assembly (para. 0021 of Picetti et al.) but does not explicitly recite attaching a driver sleeve to the first tulip assembly; rotating a bone fastener driver disposed within the driver sleeve relative to the driver sleeve to drive the bone fastener 314 into a bone without rotating the first tulip assembly.
Jackson discloses attaching a driver sleeve 110 (Fig. 21) to a tulip assembly 7 and rotating a bone fastener driver 275 disposed within the driver sleeve110 relative to the driver sleeve 110 to drive a bone fastener 3 into a bone without rotating the first tulip assembly 7 (para. 0123-0125). This configuration facilitates the surgical procedure by guiding the fastener driver while holding the tulip in place.
It would have been further obvious to a person having ordinary skill in the art before the effective filing date to perform the method of the combination (supra) with steps of attaching a driver sleeve to the first tulip assembly and rotating a bone fastener driver disposed within the driver sleeve relative to the driver sleeve to drive the bone fastener 314 into bone without rotating the first tulip assembly, in view of Jackson, to facilitate the surgical procedure by guiding the fastener driver while holding the tulip in place.
Response to Arguments
Applicant’s arguments, filed 24 June 2026, with respect to the rejection(s) of the claims as amended, have been fully considered and overcome the prior rejection(s). However, upon further consideration, new ground(s) of rejection have been made, as set forth above. Schafer (DE-9314297-U1) remains applicable as set forth in the rejection and as discussed below.
It is noted that Schafer teaches that a stabilizing system having two adjacent tulip elements may be configured with the tulips at an angle to each other with a bridge extending between them such that they do not share a wall and each comprise first and second arms (Fig. 1). This shape allows both tulips to conform in close contact to the shape of vertebral bone (id. and translation page 3, lines 7-9). Picetti et al. recognize that such a stabilizing system having two tulips can alternatively be configured with one or two fasteners, as desired (see paras. 0004, 0032 and 0034 and cf., e.g., Figs 6 and 8). Thus, for a stabilizing system already having two tulips and only one fastener, as disclosed by Picetti et al., Schafer teaches that the tulips may be shaped at an angle to each other to conform in close contact to the shape of vertebral bone.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAVID C COMSTOCK whose telephone number is (571)272-4710. The examiner can normally be reached M-F 9:00-5:00 PST.
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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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/DAVID C COMSTOCK/Examiner, Art Unit 3773
/EDUARDO C ROBERT/Supervisory Patent Examiner, Art Unit 3773
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