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 17 June 2022.
Specification
The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required: the specification fails to provide proper antecedent basis for “at least up to 5 degrees” (claim 40); rather, the specification recites “at least up to 10 degrees” (par. [0025]). See also the Rejections under 35 U.S.C. 112(b) for claim interpretation.
Applicant is reminded of the proper content of an abstract of the disclosure.
A patent abstract is a concise statement of the technical disclosure of the patent and should include that which is new in the art to which the invention pertains. The abstract should not refer to purported merits or speculative applications of the invention and should not compare the invention with the prior art.
If the patent is of a basic nature, the entire technical disclosure may be new in the art, and the abstract should be directed to the entire disclosure. If the patent is in the nature of an improvement in an old apparatus, process, product, or composition, the abstract should include the technical disclosure of the improvement. The abstract should also mention by way of example any preferred modifications or alternatives.
Where applicable, the abstract should include the following: (1) if a machine or apparatus, its organization and operation; (2) if an article, its method of making; (3) if a chemical compound, its identity and use; (4) if a mixture, its ingredients; (5) if a process, the steps.
Extensive mechanical and design details of an apparatus should not be included in the abstract. The abstract should be in narrative form and generally limited to a single paragraph within the range of 50 to 150 words in length.
See MPEP § 608.01(b) for guidelines for the preparation of patent abstracts.
Claim Objections
Claims 28-47 are objected to because of the following informalities: improper antecedence and language. Appropriate correction is required. The following amendments are suggested:
Claim 28 / line 9: “the inner walls further comprising:”
Claim 28 / line 11: “towards the lower surface, the threaded upper inner wall portion”
Claim 28 / line 14: “threaded upper inner wall portion”
Claim 28 / line 18: “the threaded upper inner wall
Claim 28 / line 19: “gap between the threads [[for]] of the threaded upper inner wall portion”
Claim 28 / line 20: “the threads [[for]] of the threaded screw head”
Claim 28 / lines 23-24: “wherein crest height [[for]] of the threads [[for]] of the threaded upper inner wall portion is greater than crest height [[for]] of the threads on the threaded screw head of the bone screw.”
Claim 29 / line 2: “between the threads [[for]] of the threaded upper inner wall portion”
Claim 29 / line 3: “the threads [[for]] of the threaded screw head.”
Claim 30 / lines 2-3: “between the threads [[for]] of the threaded upper inner wall portion is greater than [[the]] a gap between the threads [[for]] of the threaded screw head for facilitating the engagement of the threaded screw head.”
Claim 31 / lines 2-3: “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.”
Claim 32 / line 2: “adjacently located inner walls of the plurality of said inner walls”
Claim 33 / line 2: “of the recessed channels”
Claim 34 / line 2: “channels each comprise”
Claim 35 / line 1: “the non-threaded lower inner”
Claim 35 / line 3: “the threaded screw head”
Claim 35 / line 4: “the threaded screw head.”
Claim 36 / line 1: “the non-threaded lower inner”
Claim 36 / line 2: “the threaded screw head”
Claim 37 / line 2: “the threaded screw head of the bone screw.”
Claim 38 / line 2: “the threaded screw head”
Claim 39 / lines 1-2: “wherein the threads [[for]] of the threaded upper inner wall portion”
Claim 39 / line 3: “the threads [[for]] of the threaded screw head”
Claim 40 / line 3: “the threaded upper inner wall portion”
Claim 42 / line 2: “the threaded screw head”
Claim 42 / line 2: “the threaded upper inner wall portion”
Claim 42 / line 3: “the threaded screw head is advanced through the passage of the bone fixation plate.”
Claim 43 / line 9: “the inner walls further comprising:”
Claim 43 / line 11: “towards the lower surface, the threaded upper inner wall portion”
Claim 43 / line 15: “the threaded upper inner wall
Claim 43 / line 16: “gap between the threads [[for]] of the threaded upper inner wall portion”
Claim 43 / line 17: “the threads [[for]] of the threaded screw head”
Claim 43 / lines 20-21: “wherein crest height [[for]] of the threads [[for]] of the threaded upper inner wall portion is greater than crest height [[for]] of the threads on the threaded screw head of the bone screw.”
Claim 44 / lines 1-3: “wherein the gap between the threads [[for]] of the threaded upper inner wall portion is at least two times the thickness of the threads [[for]] of the threaded screw head.”
Claim 45 / lines 1-3: “wherein the gap between the threads [[for]] of the threaded upper inner wall portion is greater than [[the]] a gap between the threads [[for]] of the threaded screw head for facilitating the engagement of the threaded screw head.”
Claim 46 / lines 2-3: “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.”
Claim 47 / line 2: “adjacently located inner walls of the plurality of said inner walls”
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 40, 42, 46, and 47 are 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 40, the limitations “up to 15 degrees and at least up to 5 degrees in any direction relative to the vertical axis” render the claim indefinite. A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 40 recites the broad recitation “up to 15 degrees”, and the claim also recites “at least up to 5 degrees” which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims. The limitations are further indefinite because the limitation “at least up to 5 degrees” is unclear since “up to 5 degrees” includes all degrees less than 5 degrees, but the phrase “at least” appears to indicate that the angle is closer to 5 degrees. For examination purposes, the limitation will be interpreted as “up to 15 degrees.” One of the limitations is suggested to be deleted (see also Specification Objections).
As to claim 42, the limitation “the threads on the screw head are preferably sacrificially engaged with the threaded inner wall portion” renders the claims indefinite, because it is unclear whether the limitations following the phrase “preferably” are part of the claimed invention. For examination purposes, the limitation will be interpreted as “the threads on the screw head are configured to engage with the threaded inner wall portion”.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 29-42 and 44-47 are rejected under 35 U.S.C. 112(d) as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claims 29-42 and 44-47 fail to include all the limitations of the claim upon which they depend, since the recite “A bone fixation system”. Amendment is suggested to amend the preamble of the dependent claims to “The bone fixation system”. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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 wall further comprising: a threaded upper inner wall portion (tapped portions of 4) extending from the upper surface towards the lower surface the threaded 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 wall inner portion (col. 4 / lines 53-56), FIGS. 7-9, wherein the mismatch comprises a gap between threads for the threaded inner wall portion, wherein the gap is greater than a thickness of the threads for 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 for threads for the threaded upper inner wall portion is greater than crest height for threads on the threaded head of the bone screw, FIG. 7.
As to claim 44, Martin discloses a bone fixation system in accordance with claim 43 wherein gap between the threads for the threaded inner wall portion is at least two times the thickness of the threads for 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 a bone fixation system in accordance with claim 43 wherein gap between threads for the threaded inner wall portion is greater than the gap between the threads for the threaded screw head for facilitating 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 wall further comprising: a threaded upper inner wall portion (tapped portions of 4) extending from the upper surface towards the lower surface the threaded 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 wall inner portion (col. 4 / lines 53-56), FIGS. 7-9, wherein the mismatch comprises a gap between threads for the threaded inner wall portion, wherein the gap is greater than a thickness of the threads for 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 for threads for the threaded upper inner wall portion is greater than crest height for threads on the threaded head of the bone screw, FIG. 7.
As to claim 29, Martin discloses a bone fixation system in accordance with claim 28 wherein the gap between the threads for the threaded inner wall portion is at least two times the thickness of the threads for 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 a bone fixation system in accordance with claim 28 wherein the gap between threads for the threaded inner wall portion is greater than the gap between the threads for the threaded screw head for facilitating engagement of the threaded screw head, FIGS. 7-9.
As to claim 31, Martin discloses a bone fixation system in accordance with claim 28 wherein Pw > PH (col. 4 / lines 53-55) to allow the threads on the screw head to engage with the threaded inner wall portion as the screw head is advanced through the passage of the bone plate, FIGS. 7-9.
As to claim 32, Martin discloses a 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 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 a bone fixation system in accordance with claim 32 comprising N (6) number of 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 a bone fixation system in accordance with claim 32 wherein the recessed channels comprise a curved surface (col. 4 / lines 39-47), FIG. 2.
As to claim 37, Martin discloses a bone fixation system in accordance with claim 28 wherein height of the passage is greater than height of the threaded head of the 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 a bone fixation system in accordance with claim 28 wherein height of the threaded upper inner wall portion is greater than height of the threaded 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 a bone fixation system in accordance with claim 28 wherein threads for the threaded inner wall portion have an average thickness that is greater than an average thickness of the threads for the threaded head of the bone screw, FIG. 7.
As to claim 41, Martin discloses a 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 a bone fixation system in accordance with claim 28 wherein the threads on the screw head are preferably sacrificially engaged (see Rejections under 35 U.S.C. 112(b) above for interpretation) with the threaded inner wall portion as the screw head is advanced through the passage of the bone plate, FIGS. 7-9.
As to claim 46, Martin discloses a bone fixation system in accordance with claim 42 wherein Pw > PH (col. 4 / lines 53-55) to allow the threads on the screw head to engage with the threaded inner wall portion as the screw head is advanced through the passage of the bone plate, FIGS. 7-9.
As to claim 47, Martin discloses a 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 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 inner wall portion towards the lower surface of the bone fixation plate (claim 28); wherein the lower inner wall portion defines 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 (claim 35); wherein the lower inner wall portion comprises a convergent surface to prevent advancement of the 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 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 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 a bone fixation system in accordance with claim 28 wherein the 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 head of the bone screw for preventing advancement of the screw head (col. 14 / lines 31-35).
As to claim 36, Rapalo teaches a bone fixation system in accordance with claim 28 wherein the lower inner wall portion comprises a convergent surface (surface of 410s is convergent toward the passage axis) to prevent advancement of the 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 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 and at least up to 5 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 wall portion of the passage at an off-axis angle of 10° (which is up to 15 degrees and at least up to 5 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
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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/TRACY L KAMIKAWA/Examiner, Art Unit 3775