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 .
Examiner’s Note
Independent claim 13 is amended to bring substantially the subject matter of now cancelled claim 17. However, the language is changed to only functionally recite the cross screw, specifically “a slot configured to receive a cross screw”. Therefore, for purposes of examination the cross screw is not considered to be part of the claimed subject matter.
Claim 19 is amended to now positively recite the cross screw. Thus the cross screw is now considered to be part of the claimed invention.
Response to Arguments
Applicant's arguments filed 08/25/2025 have been fully considered but they are not persuasive.
Regarding claims 1 - 6, applicant argues that the head and body of Rocci are not removable engaged, but permanently joined. The Office respectfully disagrees. Paragraph [0065] discloses a press-fit engagement or a threaded engagement. Both would allow the head and body to be separated and thus removable.
Regarding claims 7 – 12, applicant argues that Lam fails to disclose the now claimed “insert” for engaging the cross screw. The Office respectfully disagrees. Please note that Lam is given two different interpretations. In a first interpretation the insert is considered to be the lug (ref. 15) which locks the cross screw relative to the main screw. In a second interpretation Lam does not disclose the insert and is modified by Lauf et al. (US 2022/0218398 A1). See the rejection below.
Regarding claim 13 – 16, applicant argues that Vrionis’s pin holes doesn’t disclose a slot specifically configured for retreat prevention, that it is only for pin placement. The Office respectfully disagrees. The claim requires a slot that is fully capable of receiving a cross screw. Vrionis’s main screw comprises a slot (ref. 164) which his configured to receive a pin (paragraph [0135]) which makes it fully capable of receiving a cross screw. In addition, the claim requires that the cross screw, not the slot, is configured to engage the movable portion to prevent the movable portion from retreating. It is noted that the cross screw is not claimed and thus this limitation is treated as a functional limitation of a non-claimed component. The pin of Vrionis is configured to deform the moveable portion (called the inner post) during pressure fitting with the main portion (paragraph [0135]), and thus is considered to engage the moveable portion and the deformation would be considered adequate to prevent retreating since the portions are pressure fit and deformed to one another.
Regarding claims 18 – 20, applicant argues that Santori does not teach or suggest “wherein the hook is adjustable positionable within the channel and configured to be locked in place at a plurality of positions to vary engagement depth with bone”. The Office respectfully disagrees. Col. 3, lines 30 – 40, discloses at least two positions, a first position in which the hook is in a withdrawn idle position and a second position in which the hook is in a fully operation position and the ends of the hook project out of the hook hole. In addition, Col. 4, lines 24 – 30 disclose gradual release of the hooks from bone. Thus the “gradual” release would also support a plurality of positions which would vary the depth that the hooks engage the bone tissue.
Claim Objections
Claim 3, 5, 6, 7 are objected to because of the following informalities:
Claim 3, “the screw head” should read “the removable screw head”.
Claim 5, “the screw head” should read “the removable screw head”.
Claim 6, “the screw head” should read “the removable screw head”.
Claim 7, line 5, “a cross screw” should read “the cross screw”.
Claim 8, “the system” should read “the device”.
Claim 19, “the main screw and cross screw when the peg is driven” should read “the main peg and cross screw when the main peg is driven”.
Claim 20, “the peg” should read “the main peg”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 18 – 20 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Independent claim 18 is amended to recite “wherein the hook is adjustably positionable within the channel and configured to be locked in place at a plurality of different positions to vary engagement depth with bone”. This was not found in the originally filed application. Paragraph [0037] states;
“The hooks 1335 may be expandible through pressure or twisting of an internal screw along a channel (see FIG. 14C channel 1415) in the main screw 1310. The hooks 1335 may be insertable into the channel for expansion from an end 1313 of the main screw.”
There is support for expansion (assumed to be lengthening expansion) from an end of the screw, but there is not support for being adjustably positionable …and locked in place at a plurality of positions.
Claims 19 and 20 are dependent upon claim 18 and thus are also rejected.
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 9 - 12 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 9 recites “the system includes a polymer insert within the slot”. Firstly, “the system” from independent claim 7 was deleted. Therefore, there is no longer any antecedent basis for “the system” and it is unclear what “the system” is referring to. Secondly, it is unclear if “the polymer insert” from claim 9 is the same as or different from “the inert” of claim 7. For purposes of examination, they are assumed to be the same. Claim 9 will be read as “wherein the insert is a polymer insert, within the slot, configured to engage the cross screw”.
Claim 10 recites “a polymer that engages the cross screw”. It is unclear what “a polymer” is. Is it the same as the insert, but further defining the material of the insert? Or something else? For purposes of examination the polymer is assumed to be further defining the material of the insert.
Claim 11 recites “an insert that extends through the channel and into the slot”. It is unclear if this is the same as the insert from claim 7. For purposes of examination the insert of claim 11 is assumed to be the same as the insert of claim 7.
Claim 12 recites “a set screw that extends through the channel and into the slot”. It is unclear if the set screw and the insert are the same as or different. For purposes of examination, they are assumed to be the same.
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.
Claim(s) 1 - 6 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Rocci (US 2020/0367951 A1).
Regarding claim 1, Rocci discloses a device fully capable of securing a fractured bone together (Abstract) comprising:
a main screw (Fig. 6A, ref. 72) configured to be driven through a bone fracture (the screw is defined as a bone screw, thus being fully capable of being driven through a bone fracture), and
a removable screw head (ref. 70), wherein the main screw is removeably engageable to the removable screw head (paragraph [0058] discloses that the removable screw head 70 is separate from the main screw ref. 72 and paragraph [0065] discloses a press-fit or threaded connection, thus being fully capable of being removably joined).
Regarding claim 2, Rocci discloses the device of claim 1, wherein the removable screw head has a larger circumference than the main screw (Fig. 6A).
Regarding claim 3, Rocci discloses the device of claim 2, wherein the screw head includes a tool engagement portion (Fig. 6A, refs. 71, 86).
Regarding claim 4, Rocci discloses the device of claim 3, wherein the main screw comprises internal threading that engages external threads on the removable screw head (paragraph [0065]).
Regarding claim 5, Rocci discloses the device of claim 3, wherein the main screw comprises external threading and the screw head comprises internal threading (paragraph [0065], Figs. 6C).
Regarding claim 6, Rocci discloses the device of claim 5, wherein the main screw external threading that engaged the screw head is configured to also engage bone (Fig. 6C shows the main screw to be threaded along its entire length, thus being fully capable of engaging bone).
Claim(s) 7, 8, 11 and 12 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lam et al. (US 2021/0259749 A1).
Regarding claim 7 (in a first interpretation), Lam discloses a device for securing a fractured bone together (Abstract) comprising:
a main screw (Fig. 26, ref. 25) configured to be driven through a bone fracture (the device is bone screw, thus being fully capable of being driven through a bone fracture), and
a cross screw (Fig. 26, ref. 60, paragraph [0149]),
wherein the main screw includes a slot (ref. 40) configured to receive and engage a cross screw (ref. 60) therethrough (Fig. 26), wherein the slot includes an insert (ref. 15, paragraph [0153], Fig. 26) that prevents lateral movement of the main screw relative to the cross screw (paragraph [0153]).
Regarding claim 8, Lam discloses the device of claim 7, wherein the system includes a shelf located within the slot configured to engage the cross screw (Figs. 13, 15 and 17 show a sunk counterbore of recessed portion of the slot which is taken to the shelf).
Regarding claim 11 (as best understood), Lam discloses the device of claim 7, wherein the main screw includes a channel therein that extends from a proximal end of the main screw to the slot (Fig. 26, ref. 12), wherein the system includes an insert that extends through the channel and into the slot, wherein the insert is configured to engage the cross screw (Fig. 26, ref. 15, paragraph [0153]).
Regarding claim 12 (as best understood), Lam discloses the device of claim 7, wherein the main screw includes a channel therein that extends from a proximal end of the main screw to the slot, wherein the system includes a set screw that extends through the channel and into the slot, wherein the set screw is configured to engage the set screw (paragraph [0153] discloses a set screw ref. 15 inserted into a channel ref. 12 to engage the cross screw, Fig. 26).
Claim(s) 13 - 16 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Vrionis et al. (US 2018/0092751 A1).
Regarding claim 13, Vrionis discloses a device for securing a fractured bone together (Abstract) comprises a main screw (ref. 110, Fig. 27), comprising a main portion (ref. 112) and a movable portion (refs. 106, 108), wherein the movable portion moves within the main portion (paragraph [0139]), wherein one of the main portion or movable portion comprises threads configured to engage bone (Fig. 27 shows threads on both),
wherein the main portion further comprises a slot (Fig. 27, ref. 164) configured to receive a cross screw (the slot is fully capable of receiving a cross screw since it is configured to receive a pin, paragraph [0135]), and wherein the cross screw is configured to engage the movable portion to prevent the movable portion from retreating within the main portion (paragraph [0135] discloses that the in allows for deformation of the movable portion, thus fitting the relative positions of the main screw portions which would preventing the movable portion from retreating).
Regarding claim 14, Vrionis discloses the device of claim 13, wherein the main portion includes internal threading for receiving a set screw that drives movable portion to extend a full length of the main screw (paragraph [0139]).
Regarding claim 15, Vrionis discloses the device of claim 14, wherein the movable portion includes threads configured to engage bone (Fig. 25).
Regarding claim 16, Vrionis discloses the device of claim 15, wherein the main portion includes threads configured to engage bone (Fig. 25).
Claim(s) 18 - 19 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Santori et al. (US 5,810,820).
Regarding claim 18, Santori discloses a device for securing a fractured bone (Abstract) together comprising a main peg (Fig. 1, ref. 6) comprising a channel therethrough that extends between a hole in a proximal end thereof to a hook hole (Figs. 2 – 4 show a proximal hole that extends via a channel ref. 14 to a distal hook hole at ref. 16), and a hook that (ref. 17) extends from the channel, through the hook hole, and is configured to engage bone (Fig. 4),
wherein the hook is adjustably positionable within the channel and configured to be locked in place at a plurality of positions to vary engagement depth with bone (Col. 3, lines 30 – 40, disclose at least two positions, a first position in which the hook is in a withdrawn idle position and a second position in which the hook is in a fully operation position and the ends of the hook project out of the hook hole, in addition Col. 4, lines 24 – 30 disclose gradual release of the hooks from bone. Thus the “gradual” release would also support a plurality of positions).
Regarding claim 19, Santori discloses the device of claim 18, further comprising a slot in the main peg configured to receive a cross screw of the device that inhibits movement between the main screw and cross screw when the peg is driven into bone (Fig. 1 shows a proximal slot to receive cross screw ref. 13).
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.
Claim(s) 7 and 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lam et al. (US 2021/025749 A1) in view of Kollmer (US 2016/0135861 A1).
Regarding claim 7 (in a second interpretation), Lam discloses a device for securing a fractured bone together (Abstract) comprising:
a main screw (Fig. 26, ref. 25) configured to be driven through a bone fracture (the device is bone screw, thus being fully capable of being driven through a bone fracture), and
a cross screw (Fig. 26, ref. 60, paragraph [0149]),
wherein the main screw includes a slot (ref. 40) configured to receive and engage a cross screw (ref. 60) therethrough (Fig. 26), but does is silent wherein the slot includes an insert that prevents lateral movement of the main screw relative to the cross screw.
Kollmer teaches a bone anchor comprising a main screw (ref. 32) and fastener (ref. 16) inserted into a slot of the main screw (Fig. 1), wherein the slot comprises a polymer insert that prevents lateral movement of the fastener relative to the main screw (paragraph [0073]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the slot of Lam to include the polymer insert, as taught by Kollmer, for the purpose of locking the position of the components (paragraph [0073] discloses a deformable polymer insert placed within the slot to lock the relative positions of the main screw and the fastener).
Regarding claim 9 (as best understood), Lam in view of Kollmer discloses the device of claim 7, wherein the system includes a polymer insert within the slot configured to engage the cross screw (Kollmer, paragraph [0073]).
Claim(s) 7 and 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lam et al. (US 2021/025749 A1) in view of Lauf et al. (US 2022/0218398 A1).
Regarding claim 7 (in a second interpretation), Lam discloses a device for securing a fractured bone together (Abstract) comprising:
a main screw (Fig. 26, ref. 25) configured to be driven through a bone fracture (the device is bone screw, thus being fully capable of being driven through a bone fracture), and
a cross screw (Fig. 26, ref. 60, paragraph [0149]),
wherein the main screw includes a slot (ref. 40) configured to receive and engage a cross screw (ref. 60) therethrough (Fig. 26), but does is silent wherein the slot includes an insert that prevents lateral movement of the main screw relative to the cross screw.
Lauf teaches a bone screw system (Abstract) comprising a plate body (Fig. 1, ref. 12) having a slot (paragraph [0027], refs. 40, 41, Fig. 1) and an insert (ref. 50) that is configured to prevent lateral movement of a main screw (Fig. 9, ref. 80, paragraph [0031]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the slot of Lam to include the pocket slot and insert for the purpose of preventing lateral movement of the main screw relative to the cross screw, as taught by Lauf, for the purpose of better locking the cross screw relative to the main screw.
Regarding claim 10 (as best understood), Lam in view of Lauf discloses the device of claim 7, wherein the slot comprises two scallops (the scallops are considered to be refs. 40, 41 as taught by Lauf), wherein one scallop is configured to engage the cross screw and one scallop receives a polymer that engages the cross screw to prevent lateral movement of the cross screw relative to the main screw (the polymer is considered to be the insert ref. 50 as taught by Lauf).
Claim(s) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Santori et al. (US 5,810,820) in view of Harshman et al. (US 2015/0257800 A1).
Regarding claim 20, Santori discloses the device of claim 18, except wherein the peg comprises external threads configured to engage bone.
Harshman teaches an analogous implantable device comprising a main peg (Fig. 2, ref. 206) comprising external threads configured to engage bone (Fig. 2, paragraph [0080]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the main peg such that it comprises external threads, as taught by Santori, for the purpose of assisting in engaging bone (paragraph [0080]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See PTO-892 which lists the prior art used in the current rejection not cited in prior Office Actions.
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 TESSA M MATTHEWS whose telephone number is (571)272-8817. The examiner can normally be reached M - F 8am - 1pm.
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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/TESSA M MATTHEWS/Examiner, Art Unit 3773