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 Amendment
This Office Action is responsive to the amendment filed on 28 August 2026. As directed by the amendment: claims 1, 9, 11, 13, and 20 have been amended. Claims 1-20 currently stand pending in the application.
The amendments to the claims are not sufficient to overcome the previous claim objections, which are repeated below in relevant part, in addition to further claim objections as necessitated by the current claim amendments.
The amendments to the claims are sufficient to overcome the previous rejection under 35 U.S.C. 112(b), which is accordingly withdrawn.
The amendments to the claims are sufficient to overcome the previous rejection under 35 U.S.C. 101, which is accordingly withdrawn.
Response to Arguments
Applicant’s arguments with respect to the rejections under 35 U.S.C. 103 have been considered but are moot because the new ground of rejection does not rely on any combination or interpretation of any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Claim Objections
Claims 9, 11, and 13-20 are objected to because of the following informalities: grammar. Appropriate correction is required. The following amendments are suggested:
Claim 9 / line 3: “an internal”
Claim 11 / line 2: “an internal”
Claim 13 / line 9: “engage [[a]] the bone.”
Claim 20 / line 2: “thread cutout
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.
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.
Claims 1-3, 6, 7, 9-14, and 16-20 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Application Publication No. US 2008/0154314 to McDevitt (hereinafter, “McDevitt ‘314”), in view of U.S. Patent No. US 8,894,661 to McDevitt et al. (hereinafter, “McDevitt ‘661”).
As to claim 1, McDevitt ‘314 discloses a screw assembly comprising: a cannulated screw (110) including a first thread (135) having a first handedness (par. [0077]), FIG. 4; and a blocking screw (115), configured to be inserted into bone after the cannulated screw (interpreted as language of intended use; the blocking screw is fully capable of being inserted into bone after the cannulated screw since the blocking screw is inserted into a proximal end of the cannulated screw and can be inserted therein after the cannulated screw has been implanted; even if assembled before insertion into bone, the blocking screw would be inserted into bone after the cannulated screw because the cannulated screw comprises the tip which enters the bone first, with all other components, including the blocking screw, following) and to remain implanted in the bone (to promote ingrowth, par. [0076]), wherein when the blocking screw is inserted within the cannulated screw a portion of the blocking screw extends out of a portion of the cannulated screw (the portions of the blocking screw adjacent the grooves 115, i.e. the larger diameter portions of the blocking screw, extend out of a portion of the cannulated screw by extending beyond the inward facing root of runners 140 of the cannulated screw).
As to claim 2, McDevitt ‘314 discloses the screw assembly of claim 1 wherein the cannulated screw includes a cutout (negative space between runners 140) for receiving a portion of the blocking screw (par. [0086]), FIG. 4.
As to claim 6, McDevitt ‘314 discloses the screw assembly of claim 1, wherein a major diameter of the blocking screw (at the portions of the blocking screw adjacent the grooves 115, i.e. the larger diameter portions of the blocking screw) is greater than a minor diameter of the cannulated screw (at the inward facing roots of runners 140 of the cannulated screw).
As to claim 7, McDevitt ‘314 discloses the screw assembly of claim 1, wherein the first handedness is right-hand oriented, FIG. 4.
As to claim 9, McDevitt ‘314 discloses the screw assembly of claim 1, wherein the blocking screw includes a head (proximal end of 115) at a proximal end with a drive shape (recess 153) that is one of a slotted, FIG. 4, a cruciform, a square, a multiple-square, a internal hex, a pentalobular, a hexalobular, a combination, an external, or a tamper resistant shape.
As to claim 10, McDevitt ‘314 discloses the screw assembly of claim 1, wherein the cannulated screw includes a head (proximal end of 110) at a proximal portion of the cannulated screw, FIG. 4.
As to claim 11, McDevitt ‘314 discloses the screw assembly of claim 10, wherein the head has a drive shape that is one of a slotted (slotted between runners 140), a cruciform, a square, a multiple-square, a internal hex, a pentalobular, a hexalobular, a combination, an external, or a tamper resistant shape.
As to claim 12, McDevitt ‘314 discloses the screw assembly of claim 10, wherein the cannulated screw includes a cutout (negative space between runners 140) that extends through the head of the cannulated screw.
McDevitt ‘314 is silent as to the blocking screw including a second thread having a second handedness opposite of the first handedness, wherein when the blocking screw is inserted within the cannulated screw a portion of the second thread extends out of a portion of the cannulated screw (claim 1); wherein the cannulated screw includes a thread cutout for receiving a portion of the second thread (claim 2); wherein the first and second threads have different pitches (claim 3); the second handedness is left-hand oriented (claim 7); wherein the cannulated screw includes a thread cutout that extends through the head of the cannulated screw (claim 12).
McDevitt ‘661 teaches a cannulated screw (10) including a first thread (20) having a first handedness (col. 4 / lines 62-64), FIG. 5; and a helical internal strut (45) having a second handedness opposite of the first handedness (col. 5 / lines 20-26) and a different pitch, FIG. 5.
Accordingly, 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 runners in McDevitt ‘314 to be helical, as taught by McDevitt ‘661, to allow secure interaction between the cannulated screw and the blocking screw with reduced chance of backout and since McDevitt ‘661 teaches that an internal strut on a cannulated screw can be linear or helical. The blocking screw in McDevitt ‘314 would then have complementary helical grooves to fit with the helical runners of the cannulated screw. The raised portions of the blocking screw adjacent the helical grooves can be interpreted as a wide helical second thread on the blocking screw. As taught by McDevitt ‘661, the second thread has a second handedness opposite of the first handedness so that turning of the cannulated screw does not interfere with the interaction of the cannulated and blocking screws, and also teaches the first and second threads have different pitches. When the blocking screw is inserted within the cannulated screw a portion of the second thread extends out of a portion of the cannulated screw because the second thread extends beyond the inward facing root of the helical runners of the cannulated screw and thus out of the lumen of the cannulated screw. The cannulated screw includes a thread cutout (negative space between helical runners) for receiving a portion of the second thread and that extends through the head of the cannulated screw. Since McDevitt ‘661 teaches that the second thread has a second handedness opposite of the first handedness, and the first handedness is right-hand oriented, then the second handedness is left-hand oriented.
As to claim 13, McDevitt ‘314 discloses a screw assembly comprising: a cannulated screw (110) including a first thread (135) having a first handedness (par. [0077]), FIG. 4, and a cutout (negative space between runners 140, adjacent the inward facing roots of the runners) (par. [0086]) extending a length of the cannulated screw having an opening between a cavity (lumen between inward facing roots of runners 140) and an exterior of the cannulated screw; a blocking screw (115), configured to be inserted into bone after the cannulated screw (interpreted as language of intended use; the blocking screw is fully capable of being inserted into bone after the cannulated screw since the blocking screw is inserted into a proximal end of the cannulated screw and can be inserted therein after the cannulated screw has been implanted; even if assembled before insertion into bone, the blocking screw would be inserted into bone after the cannulated screw because the cannulated screw comprises the tip which enters the bone first, with all other components, including the blocking screw, following) and to remain implanted in the bone (to promote ingrowth, par. [0076]); and wherein when the blocking screw is inserted within the cannulated screw a portion of the blocking screw extends partially out of the thread cutout and is configured to engage a bone (the portions of the blocking screw adjacent the grooves 115, i.e. the larger diameter portions of the blocking screw, extend partially out of the thread cutout by extending beyond the inward facing root of runners 140 of the cannulated screw, and are fully capable of engaging bone that grows inward).
As to claim 16, McDevitt ‘314 discloses the screw assembly of claim 13, wherein a major diameter of the blocking screw (at the portions of the blocking screw adjacent the grooves 115, i.e. the larger diameter portions of the blocking screw) is greater than a minor diameter of the cannulated screw (at the inward facing roots of runners 140 of the cannulated screw).
As to claim 17, McDevitt ‘314 discloses the screw assembly of claim 13, wherein the first handedness is right-hand oriented, FIG. 4.
As to claim 18, McDevitt ‘314 discloses the screw assembly of claim 13, wherein the blocking screw includes a head (proximal end of 115) at a proximal end with a drive shape (recess 153).
As to claim 19, McDevitt ‘314 discloses the screw assembly of claim 13, wherein the cannulated screw includes a head (proximal end of 110) at a proximal portion of the cannulated screw with a drive shape (shape between runners 140), FIG. 4.
As to claim 20, McDevitt ‘314 discloses the screw assembly of claim 19, wherein the cutout that extends through the head of the cannulated screw, FIG. 4.
McDevitt ‘314 is silent as to a thread cutout extending a length of the cannulated screw having a helical opening; the blocking screw including a second thread having a second handedness opposite of the first handedness; wherein when the blocking screw is inserted within the cannulated screw a portion of the second thread extends partially out of the thread cutout (claim 13); wherein the first and second threads have different pitches (claim 14); the second handedness is left-hand oriented (claim 17); the thread cutout that extends through the head of the cannulated screw (claim 20).
McDevitt ‘661 teaches a cannulated screw (10) including a first thread (20) having a first handedness (col. 4 / lines 62-64), FIG. 5; and a helical internal strut (45) having a second handedness opposite of the first handedness (col. 5 / lines 20-26) and a different pitch, FIG. 5.
Accordingly, 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 runners in McDevitt ‘314 to be helical, as taught by McDevitt ‘661, to allow secure interaction between the cannulated screw and the blocking screw with reduced chance of backout and since McDevitt ‘661 teaches that an internal strut on a cannulated screw can be linear or helical. The blocking screw in McDevitt ‘314 would then have complementary helical grooves to fit with the helical runners of the cannulated screw. The raised portions of the blocking screw adjacent the helical grooves can be interpreted as a wide helical second thread on the blocking screw. As taught by McDevitt ‘661, the second thread has a second handedness opposite of the first handedness so that turning of the cannulated screw does not interfere with the interaction of the cannulated and blocking screws, and also teaches the first and second threads have different pitches. When the blocking screw is inserted within the cannulated screw a portion of the second thread extends out of a portion of the cannulated screw because the second thread extends beyond the inward facing root of the helical runners of the cannulated screw and thus out of the lumen of the cannulated screw. The cannulated screw includes a thread cutout (negative space between helical runners, adjacent the inward facing roots of the runners) extending a length of the cannulated screw having a helical opening between a cavity (lumen between inward facing roots of runners 140) and an exterior of the cannulated screw, that receives a portion of the second thread and that extends through the head of the cannulated screw. When the blocking screw is inserted within the cannulated screw a portion of the second thread extends partially radially out of the thread cutout which is adjacent the inward facing roots of the runners, and is configured to engage a bone (the portions of the blocking screw adjacent the grooves 115, i.e. the larger diameter portions of the blocking screw, extend partially out of the thread cutout by extending beyond the inward facing root of runners 140 of the cannulated screw, and are fully capable of engaging bone that grows inward). Since McDevitt ‘661 teaches that the second thread has a second handedness opposite of the first handedness, and the first handedness is right-hand oriented, then the second handedness is left-hand oriented.
Claims 4, 5, and 15 are rejected under 35 U.S.C. 103 as being unpatentable over McDevitt ‘314 in view of McDevitt ‘661 (hereinafter, “McDevitt ‘314/McDevitt ‘661”), as applied to claims 1-3, 6, 7, 9-14, and 16-20 above, and further in view of U.S. Patent Application Publication No. US 2022/0287750 to McKay et al. (hereinafter, “McKay”).
As to claims 4, 5, and 15, McDevitt ‘314/McDevitt ‘661 are silent as to wherein the first thread has at least two different pitches and wherein the first thread has a first threaded section and a second threaded section having different pitches.
McKay teaches that a screw can have two different pitches, where a first threaded section and a second threaded section have different pitches (par. [0037]), FIG. 5, to stimulate bone growth.
Accordingly, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to provide two threaded sections of the first thread in McDevitt ‘314/McDevitt ‘661, the sections having different pitches, with the tip of the first thread having a greater pitch, to stimulate bone growth.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over McDevitt ‘314/McDevitt ‘661, as applied to claims 1-3, 6, 7, 9-14, and 16-20 above, and further in view of U.S. Patent No. US 10,993,754 to Kuntz et al. (hereinafter, “Kuntz”).
As to claim 8, McDevitt ‘314/McDevitt ‘661 are silent as to wherein the first handedness is left-hand oriented, and the second handedness is right-hand oriented.
Kuntz teaches that threads on a screw can be left or right hand oriented.
Accordingly, it would have been obvious to make the first handedness of the first thread left-hand oriented, and the second handedness of the second thread right-hand oriented, since the mere reversal of the essential working parts of a device involves only routine skill in the art, and Kuntz teaches that a screw may have either handedness.
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 TRACY L KAMIKAWA whose telephone number is (571)270-7276. The examiner can normally be reached M-F 10:00-6:30 PM.
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, Kevin Truong, can be reached at 571-272-4705. 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.
/TRACY L KAMIKAWA/Examiner, Art Unit 3775
Prosecution Insights