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 .
Priority
The priority date is 21 August 2024.
Claim Objections
Claims 9 and 11 are objected to because of the following informalities: grammar. Appropriate correction is required. The following amendments are suggested:
Claim 9 / line 2: “an internal”
Claim 9 / line 3: “an external”
Claim 11 / line 2: “an internal”
Claim 11 / line 3: “an external”
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.
Claim 20 is rejected under 35 U.S.C. 112(b) 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.
As to claim 20, the limitation “a thread cutout” renders the claim indefinite, because it is unclear if this refers back to a thread cutout previously recited in claim 13, line 2, or to a different thread cutout. For examination purposes, the limitation will be interpreted in the former instance, as the thread cutout. Amendment is suggested to “wherein the thread cutout extends through the head of the cannulated screw.”
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claims 13-20 are rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101).
Claims 13-20 are rejected under 35 U.S.C. 101 because they are drawn to non-statutory subject matter. In claim 13, line 8, applicant positively recites part of a human, “engages a bone.” Thus claims 13-20 include a human within their scope and are non-statutory. Amendment is suggested to: is configured to engage a bone.
A claim directed to or including within its scope a human is not considered to be patentable subject matter under 35 U.S.C. 101. The grant of a limited, but exclusive property right in a human being is prohibited by the Constitution. In re Wakefield, 422 F.2d 897, 164 USPQ 636 (CCPA 1970).
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 No. US 8,894,661 to McDevitt et al. (hereinafter, “McDevitt”).
As to claim 1, McDevitt discloses a screw assembly comprising: a cannulated screw (10) including a first thread (20) having a first handedness (col. 4 / lines 62-64), FIG. 5; and a blocking screw (60), FIG. 7.
As to claim 7, McDevitt discloses the screw assembly of claim 1, wherein the first handedness is right-hand oriented, FIG. 5.
As to claim 9, McDevitt discloses the screw assembly of claim 1, wherein the blocking screw includes a head (80) at a proximal end, FIG. 1, with a drive shape that is one of a slotted, a cruciform, a square, a multiple-square, a internal hex, a pentalobular, a hexalobular, a combination, a external (the head 80 has an external shape that can be manually driven), or a tamper resistant shape.
As to claim 10, McDevitt discloses the screw assembly of claim 1, wherein the cannulated screw includes a head (where a head is commonly understood to mean an upper part; the head is the proximal part of the cannulated screw, including the first rotation) at a proximal portion of the cannulated screw, FIG. 5.
McDevitt 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); wherein a major diameter of the blocking screw is greater than a minor diameter of the cannulated screw (claim 6); the second handedness is left-hand oriented (claim 7); wherein the head has a drive shape that is one of a slotted, a cruciform, a square, a multiple-square, a internal hex, a pentalobular, a hexalobular, a combination, a external, or a tamper resistant shape (claim 11); wherein the cannulated screw includes a thread cutout that extends through the head of the cannulated screw (claim 12).
In another embodiment, McDevitt teaches that the struts (45) on the interior of the cannulated screw may be replaced with recesses (45A), FIG. 37, with the grooves (70) on the blocking screw correspondingly replaced by corresponding ribs (not shown).
Accordingly, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to replace the struts (45) on the interior of the cannulated screw shown in FIG. 5 with recesses/a thread cutout, and to replace the grooves (70) on the blocking screw with ribs to be received in the recesses/thread cutout on the interior of the cannulated screw, since the mere reversal of the essential working parts of a device involves only routine skill in the art. The recesses and the ribs would be complementarily shaped helical structures as disclosed by McDevitt (col. 5 / lines 20-26). The recesses in the cannulated screw are a thread cutout because they are cut out of the interior of the first thread, including through the head of the cannulated screw as defined above. The blocking screw, modified to have a helical rib, would thus include a second thread (the helical rib) having a second handedness opposite of the first handedness (col. 5 / lines 20-26), FIG. 5, 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 (since the second thread is received in the recesses in the cannulated screw, so that the portions of the second thread between the turns of the first thread of the cannulated screw would extend out of that portion of the cannulated screw, i.e. beyond the root of the first thread). The first and second threads have different pitches as taught by McDevitt (col. 5 / lines 24-26). A major diameter of the blocking screw is greater than a minor diameter of the cannulated screw, since the second thread on the blocking screw extends into the recess/thread cutout on the interior of the first thread of the cannulated screw, i.e. the second thread extends beyond the minor diameter of the cannulated screw. Since the first thread is right-hand oriented, FIG. 5, and the second thread is in the opposite direction, the second thread is left-hand oriented. The head of the cannulated screw has a slotted shape due to the recesses, i.e. slots, on the interior of the cannulated screw. This is a drive shape since the cannulated screw is driven by interaction of the slot with the rib on the blocking screw.
As to claim 13, McDevitt discloses a screw assembly comprising: a cannulated screw (10) including a first thread (20) having a first handedness (col. 4 / lines 62-64), FIG. 5; a blocking screw (60), FIG. 7.
As to claim 17, McDevitt discloses the screw assembly of claim 13, wherein the first handedness is right-hand oriented, FIG. 5.
As to claim 18, McDevitt discloses the screw assembly of claim 13, wherein the blocking screw includes a head (80) at a proximal end, FIG. 1, with a drive shape (the head 80 has an external shape that can be manually driven).
As to claim 19, McDevitt discloses the screw assembly of claim 13, wherein the cannulated screw includes a head (where a head is commonly understood to mean an upper part; the head is the proximal part of the cannulated screw, including the first rotation) at a proximal portion of the cannulated screw, FIG. 5.
McDevitt is silent as to a thread cutout extending a length of the cannulated screw having a helical opening between a cavity and an exterior of the cannulated screw; the blocking screw including a second thread having a second handedness opposite of the first handedness; and wherein when the blocking screw is inserted within the cannulated screw a portion of the second thread extends partially out of the thread cutout and engages a bone (claim 13); wherein the first and second threads have different pitches (claim 14); wherein a major diameter of the blocking screw is greater than a minor diameter of the cannulated screw (claim 16); the second handedness is left-hand oriented (claim 17); the head of the cannulated screw has a drive shape (claim 19); wherein the cannulated screw includes a thread cutout that extends through the head of the cannulated screw (claim 20).
In another embodiment, McDevitt teaches that the struts (45) on the interior of the cannulated screw may be replaced with recesses (45A), FIG. 37, with the grooves (70) on the blocking screw correspondingly replaced by corresponding ribs (not shown).
Accordingly, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to replace the struts (45) on the interior of the cannulated screw shown in FIG. 5 with recesses/a thread cutout, and to replace the grooves (70) on the blocking screw with ribs to be received in the recesses/thread cutout on the interior of the cannulated screw, since the mere reversal of the essential working parts of a device involves only routine skill in the art. The recesses and the ribs would be complementarily shaped helical structures as disclosed by McDevitt (col. 5 / lines 20-26). The recesses in the cannulated screw are a thread cutout because they are cut out of the interior of the first thread, including through the head of the cannulated screw as defined above. The thread cutout extends a length of the cannulated screw, as seen in the opposite strut 45 extending the length of the cannulated screw in FIG. 5. The thread cutout is a helical opening or negative space between a cavity (interior to the root of the first thread) and an exterior (crest of the first thread) of the cannulated screw, since the thread cutout is cut out of the interior of the first thread/cut into the first thread. The blocking screw, modified to have a helical rib, would thus include a second thread (the helical rib) having a second handedness opposite of the first handedness (col. 5 / lines 20-26), FIG. 5, wherein when the blocking screw is inserted within the cannulated screw a portion of the second thread extends partially out of the thread cutout (where the second thread extends between the turns of the first thread and thus out of the thread cutout of the first thread) and engages a bone (if so placed adjacently). The first and second threads have different pitches as taught by McDevitt (col. 5 / lines 24-26). A major diameter of the blocking screw is greater than a minor diameter of the cannulated screw, since the second thread on the blocking screw extends into the recess/thread cutout on the interior of the first thread of the cannulated screw, i.e. the second thread extends beyond the minor diameter of the cannulated screw. Since the first thread is right-hand oriented, FIG. 5, and the second thread is in the opposite direction, the second thread is left-hand oriented. The head of the cannulated screw has a slotted shape due to the recesses, i.e. slots, on the interior of the cannulated screw. This is a drive shape since the cannulated screw is driven by interaction of the slot with the rib on the blocking screw.
Claims 4, 5, and 15 are rejected under 35 U.S.C. 103 as being unpatentable over McDevitt 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 is 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, 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 in view of U.S. Patent No. US 10,993,754 to Kuntz et al. (hereinafter, “Kuntz”).
As to claim 8, McDevitt is 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
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