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 April 2026. As directed by the amendment: claims 1-27 are cancelled, and claims 28-47 have been amended. Claims 28-47 currently stand pending in the application.
The amendments to the claims and the abstract are sufficient to overcome the previous specification objections, which are correspondingly withdrawn.
The amendments to the claims are sufficient to overcome the previous claim objections, which are correspondingly withdrawn.
The amendments to the claims are sufficient to overcome the rejections under 35 U.S.C. 112(b) and 112(d), which are correspondingly withdrawn.
Response to Arguments
Applicant's arguments filed 28 April 2026 have been fully considered but they are not persuasive. As to the rejections under 35 U.S.C. 102(a)(1)/(2) as anticipated by U.S. Patent No. US 9,782,208 to Martin, Applicant contends that the claimed limitation “in-use” means that the upper and lower surfaces directly engage with the bone screw. Examiner respectfully submits that the claimed phrase “the bone fixation plate comprising an in-use upper surface and an in-use lower surface” is interpreted to mean that, when the bone plate is in-use, one of its surfaces is the upper surface and one is the lower surface, i.e. when the bone plate is applied to a bone, or in-use, the bone plate takes a position such that there are upper (facing away from bone) and lower (bone facing) surfaces.
Applicant contends that the upper and lower surfaces are upper- and lower-most regions of the hole 4, i.e. internal regions of the hole. The claim limitation recites that the plate has in-use upper and lower surfaces, not that the passage has in-use upper and lower surfaces. The claim continues on to recite at least one opening formed on the upper and lower surfaces to form a passage extending from the upper surface to the lower surface. This is interpreted to mean that there are openings in the upper and lower surfaces of the plate, that are the openings of the passage/screw hole, i.e. the passage/screw hole opens out into the upper and lower surfaces of the plate at the openings. If, as argued by Applicant, the in-use upper and lower surfaces are upper- and lower-most regions of the hole 4, then the opening formed on the upper and lower surfaces and the passage would refer to the same structure, the hole. In this interpretation, Applicant asserts, in this interpretation, that the lower-most region of the hole in Martin remains unengaged by the bone screw and thus is not in-use. Examiner respectfully submits that the term in-use is not in reference to any sort of engagement with the bone screw. The limitation makes no reference to interaction with the bone screw. Examiner notes that even the instant application does not disclose that a lower-most region of the hole is engaged by the bone screw (FIG. 8). If the lower-most region of the hole is interpreted broadly enough to be supported by the instant specification, e.g. because the screw head contacts a concave portion of the lower region of the hole, then Martin as well would meet this interpretation since any lower portion, e.g. lower half, of the passage could be interpreted as the lower-most region, and Martin’s bone screw does engage some portion of the lower region of the passage.
Applicant contends that Martin’s device does not point toward the problem of potential injury and therefore there is no need to have the screw head sit within the passageway of the plate. In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., preventing potential injury; the threaded screw head sitting well within the passageway of the plate; bowl shape) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). Any features that Applicant contends are lacking in Martin are remedied by modification in view of US 10,993,750 to Rapalo et al. Applicant appears to be arguing that because the convergent bowl shape (note: bowl shape not claimed) in the instant application includes the benefit of the head of the screw to sit within the passage of the bone plate, but Martin does not disclose requiring the head of the screw to sit within the passage of the plate, then it is unsurprising that Martin does not disclose a convergent bowl shape. Examiner notes that the motivation to modify Martin in view of Rapalo, which does disclose the claimed limitations of a convergent configuration/surface to prevent advancement of the screw head through the passage, is to prevent the screw head from being pulled through the entire passage, as taught by Rapalo. The motivation of requiring the head of the screw to sit within the passage of the plate is not relied upon, and it need not be since this is not claimed.
Applicant contends that because Martin’s bone screw has a generally convergent profile which encourages gradual interlocking of the threads of the bone screw and the hole as a result of the progressive and effective jamming of the head into the hole, which reduces risk of the screw unscrewing, then it is possible to prevent further axial advancement of the screw without having a non-threaded lower inner wall portion that comprises a convergent bowl shape and functions as a hard stop for the screw. Applicant contends that this is a teaching away. Examiner respectfully submits that Martin makes no remarks critical of a non-threaded lower inner wall portion defining a convergent configuration/surface to prevent advancement of the screw head through the passage, which is required to demonstrate a teaching away. Just because a prior art product functions satisfactorily does not mean that a skilled artisan would not try to improve it. Providing Martin’s device with the non-threaded lower inner wall portion defining a convergent configuration/surface to prevent advancement of the screw head through the passage, as taught by Rapalo, would further ensure that the screw head is not pulled through the entire passage, in addition to and complementarily with the gradual interlocking of the screw/hole threads as disclosed by Martin.
Applicant contends that even if one of ordinary skill were to consider Martin in view of Rapalo, Martin’s screw head would be jammed in place before reaching the non-threaded lower inner wall portion, and if this feature were included with the Martin device, arguably this would restrict angulation of the screw. Examiner respectfully submits that even if Martin’s screw head is jammed in place before reaching the non-threaded lower inner wall portion, which Examiner notes is speculation, this does not mean that the non-threaded lower inner wall portion is rendered useless; the non-threaded lower inner wall portion would still prevent further undesired movement of the screw through the passage, if for example excessive force is applied to overcome the jamming, or if the jamming loosens over time and due to movement of the patient.
Applicant speculates that providing a non-threaded lower inner wall portion would make it difficult to insert the Martin bone screw at an angle due to the bone screw thread protruding outwardly along the body of the screw. Examiner respectfully submits that Rapalo’s bone screw also has a bone screw thread protruding outwardly along the body of the screw (FIG. 2), and is able to interact with the non-threaded lower inner wall portion which is part of a variable angle hole, and therefore it is reasonable that providing a non-threaded lower inner wall portion to Martin’s passage would allow interaction with a screw at variable angles.
As to Rapalo, Applicant contends that the features 410 are tabs and not a non-threaded lower inner wall portion extending from a lower part of the threaded upper inner wall portion towards the lower surface of the bone fixation plate because the tabs 410 are not part of the same inner wall and do not extend towards the lower surface of the plate. Rather, Applicant contends that the Rapalo tabs are inwardly projecting structures that are located in the lower region of the screw hole, and do not extend from and thereby forms a smooth continuous inner wall with the upper threaded inner wall portion. Examiner respectfully submits that the Rapalo tabs are part of the same inner wall because they form an interior of the passage just as much as the threaded upper inner wall portion; both portions of the inner wall interact with the same screw head. As seen in FIG. 10B of Rapalo, the tabs extend inwardly just as the threads do; it is unclear how these are not part of the same inner wall. The Rapalo tabs do extend towards the lower surface of the plate because of their height; the tabs extend from the threaded wall portion towards the lower surface of the plate because they are three-dimensional structures, and the body thickness/height of the tabs spans the distance between/extends from the threaded wall portion towards the lower surface of the plate. The claim does not require a smooth continuous inner wall with the upper threaded inner wall portion, and Examiner notes that the instant application also does not disclose a smooth continuous inner wall with the upper threaded inner wall portion. FIG. 8 of the instant application shows that the non-threaded lower inner wall portion is not smooth or continuous with the upper threaded inner wall portion but rather juts out at angles form the threaded portion, similarly to Rapalo FIG. 10B. The claims do require that the non-threaded lower inner wall portion is convergent, which means that the non-threaded lower inner wall portion extends inwardly, just as the tabs of Rapalo do. Applicant contends that the word “tab” suggests these are functional features rather than a surface that extends from the threaded portion. Examiner submits that functional features have surfaces.
Claim Rejections - 35 USC § 102
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 43-45 are rejected under 35 U.S.C. 102(a)(1)/(2) as anticipated by U.S. Patent No. US 9,782,208 to Martin.
As to claim 43, Martin discloses a bone fixation system for treatment of bones, the bone fixation system comprising: a bone fixation plate (2), FIG. 1, configured and dimensioned for application to a patient's bone (col. 4 / lines 23-25), the bone fixation plate comprising an in-use upper surface and an in-use lower surface with at least one opening (openings leading into 4) formed on the upper and lower surfaces to form a passage (4) extending from the upper surface to the lower surface (col. 4 / lines 36-37), FIGS. 1-3 and 7-9; the passage being defined by inner walls (tapped portions of 4) extending from the upper surface to the lower surface, FIG. 2, the inner walls having a height extending between the upper surface and the lower surface, the inner walls further comprising: a threaded upper inner wall portion (tapped portions of 4) extending from the upper surface towards the lower surface, the threaded upper inner wall portion having threads with a thread pitch (Pw) (pitch of the tapping of passage 4, col. 4 / lines 53-56); and at least one bone screw (3) with a threaded screw head (3a) having threads (3d) with a thread pitch (PH), FIGS. 4-9, whereby thread profile for the threaded screw head is mismatched relative to thread profile of the threaded upper inner wall portion (col. 4 / lines 53-56), FIGS. 7-9, wherein the mismatch comprises a gap between the threads of the threaded upper inner wall portion, wherein the gap is greater than a thickness of the threads of the threaded screw head (since about 1.5-2 threads, or at least more than 1 thread, of the threaded screw head fit in one gap between threads for the threaded inner wall portion, as shown on the right in FIG. 9), for facilitating engagement of the threaded screw head when interfaced with the threaded upper inner wall portion for effecting variable angle anchoring of the threaded screw head during use (col. 4 / line 65 – col. 5 / line 13), FIGS. 7-9, wherein crest height of the threads of the threaded upper inner wall portion is greater than crest height of the threads on the threaded screw head of the bone screw, FIG. 7.
As to claim 44, Martin discloses the bone fixation system in accordance with claim 43 wherein the gap between the threads of the threaded upper inner wall portion is at least two times the thickness of the threads of the threaded screw head (FIG. 9 shows that the gap between the threads for the threaded inner wall portion is about two times the thickness of the threads for the threaded screw head; additionally, the gap may be measured at the widest point between the threads of the threaded inner wall portion, and the thickness of the threads for the threaded screw head may be measured nearer a crest of the threads, so that the gap is at least two times the thickness).
As to claim 45, Martin discloses the bone fixation system in accordance with claim 43 wherein the gap between the threads of the threaded upper inner wall portion is greater than a gap between the threads of the threaded screw head for facilitating the engagement of the threaded screw head, FIGS. 7-9.
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 28-42, 46, and 47 are rejected under 35 U.S.C. 103 as being unpatentable over Martin in view of U.S. Patent No. US 10,993,750 to Rapalo et al. (hereinafter, “Rapalo”).
As to claim 28, Martin discloses a bone fixation system for treatment of bones, the bone fixation system comprising: a bone fixation plate (2), FIG. 1, configured and dimensioned for application to a patient's bone (col. 4 / lines 23-25), the bone fixation plate comprising an in-use upper surface and an in-use lower surface with at least one opening (openings leading into 4) formed on the upper and lower surfaces to form a passage (4) extending from the upper surface to the lower surface (col. 4 / lines 36-37), FIGS. 1-3 and 7-9; the passage being defined by inner walls (tapped portions of 4) extending from the upper surface to the lower surface, FIG. 2, the inner walls having a height extending between the upper surface and the lower surface, the inner walls further comprising: a threaded upper inner wall portion (tapped portions of 4) extending from the upper surface towards the lower surface, the threaded upper inner wall portion having threads with a thread pitch (Pw) (pitch of the tapping of passage 4, col. 4 / lines 53-56); and at least one bone screw (3) with a threaded screw head (3a) having threads (3d) with a thread pitch (PH), FIGS. 4-9, whereby thread profile for the threaded screw head is mismatched relative to thread profile of the threaded upper inner wall portion (col. 4 / lines 53-56), FIGS. 7-9, wherein the mismatch comprises a gap between the threads of the threaded upper inner wall portion, wherein the gap is greater than a thickness of the threads of the threaded screw head (since about 1.5-2 threads, or at least more than 1 thread, of the threaded screw head fit in one gap between threads for the threaded inner wall portion, as shown on the right in FIG. 9) for facilitating engagement of the threaded screw head when interfaced with the threaded upper inner wall portion for effecting variable angle anchoring of the threaded screw head during use (col. 4 / line 65 – col. 5 / line 13), FIGS. 7-9, and wherein crest height of the threads of the threaded upper inner wall portion is greater than crest height of the threads on the threaded screw head of the bone screw, FIG. 7.
As to claim 29, Martin discloses the bone fixation system in accordance with claim 28 wherein the gap between the threads of the threaded upper inner wall portion is at least two times the thickness of the threads of the threaded screw head (FIG. 9 shows that the gap between the threads for the threaded inner wall portion is about two times the thickness of the threads for the threaded screw head; additionally, the gap may be measured at the widest point between the threads of the threaded inner wall portion, and the thickness of the threads for the threaded screw head may be measured nearer a crest of the threads, so that the gap is at least two times the thickness).
As to claim 30, Martin discloses the bone fixation system in accordance with claim 28 wherein the gap between the threads of the threaded upper inner wall portion is greater than a gap between the threads of the threaded screw head for facilitating the engagement of the threaded screw head, FIGS. 7-9.
As to claim 31, Martin discloses the bone fixation system in accordance with claim 28 wherein Pw > PH (col. 4 / lines 53-55) to allow the threads on the threaded screw head to engage with the threaded upper inner wall portion as the threaded screw head is advanced through the passage of the bone fixation plate, FIGS. 7-9.
As to claim 32, Martin discloses the bone fixation system in accordance with claim 28 wherein the passage is defined by a plurality of said inner walls (tapped portions of 4) such that adjacently located inner walls of the plurality of said inner walls are separated by a recessed channel (5) extending radially away from a central axis of the passage (col. 4 / lines 39-47), FIG. 2.
As to claim 33, Martin discloses the bone fixation system in accordance with claim 32 comprising N (6) number of the recessed channels and wherein the N recessed channels are angularly spaced at a distance of 360°/N relative to the central axis of the passage (col. 4 / lines 39-47), FIG. 2.
As to claim 34, Martin discloses the bone fixation system in accordance with claim 32 wherein the recessed channels each comprise a curved surface (col. 4 / lines 39-47), FIG. 2.
As to claim 37, Martin discloses the bone fixation system in accordance with claim 28 wherein height of the passage is greater than height of the threaded screw head of the bone screw (as shown in FIG. 9, the height of the passage is greater than the height of the right side of the threaded head of the screw, since the top of the screw head on the right side is recessed below the top of the passage).
As to claim 38, Martin discloses the bone fixation system in accordance with claim 28 wherein height of the threaded upper inner wall portion is greater than height of the threaded screw head of the bone screw (as shown in FIG. 9, the height of the threaded upper inner wall portion is greater than the height of the right side of the threaded head of the screw, since the top of the screw head on the right side is recessed below the top of the threaded upper inner wall portion).
As to claim 39, Martin discloses the bone fixation system in accordance with claim 28 wherein the threads of the threaded upper inner wall portion have an average thickness that is greater than an average thickness of the threads of the threaded screw head of the bone screw, FIG. 7.
As to claim 41, Martin discloses the bone fixation system in accordance with claim 28 wherein the threaded upper inner wall portion tapers in a radially inward and downward direction (one thread revolution on the threaded upper inner wall portion tapers radially inward and downward along a top surface).
As to claim 42, Martin discloses the bone fixation system in accordance with claim 28 wherein the threads on the threaded screw head are configured to engage with the threaded upper inner wall portion as the threaded screw head is advanced through the passage of the bone fixation plate, FIGS. 7-9.
As to claim 46, Martin discloses the bone fixation system in accordance with claim 42 wherein Pw > PH (col. 4 / lines 53-55) to allow the threads on the threaded screw head to engage with the threaded upper inner wall portion as the threaded screw head is advanced through the passage of the bone fixation plate, FIGS. 7-9.
As to claim 47, Martin discloses the bone fixation system in accordance with claim 42 wherein the passage is defined by a plurality of said inner walls (tapped portions of 4) such that adjacently located inner walls of the plurality of said inner walls are separated by a recessed channel (5) extending radially away from a central axis of the passage (col. 4 / lines 39-47), FIG. 2.
Martin is silent as to a non-threaded lower inner wall portion extending from a lower part of the threaded upper inner wall portion towards the lower surface of the bone fixation plate (claim 28); wherein the non-threaded lower inner wall portion defines a convergent configuration terminating in an opening with a width that is less than a width of the threaded screw head of the bone screw for preventing advancement of the threaded screw head (claim 35); wherein the non-threaded lower inner wall portion comprises a convergent surface to prevent advancement of the threaded screw head through the passage (claim 36).
As to claim 28, Rapalo teaches a bone fixation system for treatment of bones, the bone fixation system comprising: a bone fixation plate (400) configured and dimensioned for application to a patient's bone, FIGS. 10A-10B, the bone fixation plate comprising an in-use upper surface and an in-use lower surface with at least one opening formed on the upper and lower surfaces to form a passage (402) extending from the upper surface to the lower surface; the passage being defined by an inner wall extending from the upper surface to the lower surface, the inner wall having a height extending between the upper surface and the lower surface, the inner wall further comprising: a threaded upper inner wall portion extending from the upper surface towards the lower surface, the threaded upper inner wall portion having threads (416) (col. 14 / lines 53-65) with a thread pitch (PW); a non-threaded lower inner wall portion (410) extending from a lower part of the threaded upper inner wall portion towards the lower surface of the bone fixation plate, FIG. 10B; and at least one bone screw with a threaded screw head having threads (col. 14 / lines 53-65) with a thread pitch (PH) for effecting variable angle anchoring of the threaded screw head during use (col. 15 / lines 9-15).
As to claim 35, Rapalo teaches the bone fixation system in accordance with claim 28 wherein the non-threaded lower inner wall portion defines a convergent configuration (410s converge toward each other) terminating in an opening (between 410s) with a width that is less than a width of the threaded screw head of the bone screw for preventing advancement of the threaded screw head (col. 14 / lines 31-35).
As to claim 36, Rapalo teaches the bone fixation system in accordance with claim 28 wherein the non-threaded lower inner wall portion comprises a convergent surface (surface of 410s is convergent toward the passage axis) to prevent advancement of the threaded screw head through the passage (col. 14 / lines 31-35).
Accordingly, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to include as part of Martin’s passage, a non-threaded lower inner wall portion comprising tabs as taught by Rapalo (tabs 410), that extend from a lower part of the threaded inner wall portion in Martin towards the lower surface of the bone fixation plate, and that define a convergent configuration terminating in an opening with a width that is less than a width of the threaded head of the bone screw for preventing advancement of the screw head, to prevent the screw head from being pulled through the entire passage, as taught by Rapalo. As taught by Rapalo and required by Martin, the lower inner wall portion comprises recesses between adjacent tabs that allow for variable angle anchoring of the screw. The tabs would be aligned with the threaded upper inner wall portions of Martin, and the recesses between tabs would be aligned with Martin’s recessed channels, to accommodate variable angle anchoring of the screw. The height of the passage would be made to accommodate the tabs below the threaded wall portion. As taught by Rapalo, the tabs would converge further inwardly than the threaded wall portion, terminating in a smaller opening to prevent the screw head from being pulled through the entire passage.
As to claim 40, Martin discloses wherein the passage comprises a vertical axis (V-V), wherein the threaded screw head is configured to engage with the threaded upper inner wall portion of the passage at an off-axis angle in any direction relative to the vertical axis (at least in part due to the equiangularly spaced recessed channels 5, col. 5 / lines 4-7), but is silent as to the angle being up to 15 degrees.
In another embodiment, Martin teaches that the screw head is configured to engage with the threaded wall portion of the passage at an off-axis angle of 10° relative to the vertical axis of the passage (col. 5 / lines 48-49).
Accordingly, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to configure the threaded screw head in Martin’s earlier embodiment (FIGS. 7-9) to engage with the threaded upper inner wall portion of the passage at an off-axis angle of 10° (which is up to 15 degrees) in any direction relative to the vertical axis of the passage, since where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art, and since Martin teaches that this is a reasonable degree of angulation of the screw in the passage.
Conclusion
THIS ACTION IS MADE FINAL. 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.
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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.
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/TRACY L KAMIKAWA/Examiner, Art Unit 3775
Prosecution Insights