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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 28 May 2025 and the supplemental amendment filed on 28 August 2025 have been entered.
Response to Amendment
Applicant’s amendments, filed 28 May 2025 and 28 August 2025, have been acknowledged. Claims 1, 2, 27, 30, 33, 34, 43, 44, and 46 are amended. Claims 49 and 51-55 are new. Claims 17, 19, 31, 32, 36, 37, 48 and 50 are cancelled and claims 4-16 were previously cancelled.
Claims 1-3, 18, 20-30, 33-35, 38-47, 49, and 51-55 are pending in the instant application.
Response to Arguments
Applicant’s arguments filed 28 May 2025, with respect to objections to claims 19, 27, 31, 33 and 34 have been fully considered and are persuasive. The objections to claims 19, 27, 31, 33 and 34 have been withdrawn.
Regarding the objection to claim 25, Applicant is correct that claims 1 and 25 state “screw thread”, but the Examiner is highlighting that dependent claims 2, 18, 20, 21, 24, 28, 30, 33, 35, 37-40, 42, 45, 47, and 50 recite “the thread”. No other dependent claim recites “the screw thread”. The Examiner is objecting to the lack of consistency in using “the screw thread” vs “the thread”.
Regarding the objections to claims 42 and 45, the Examiner agrees there is only one “a pitch of the thread of a first sub-section” and “pitch of the thread of a second sub-section”. Examiner is specifically objecting to “the thread” since the sub-sections have not been previously presented, the threads of the sub-sections have also not been previously presented and therefore lack antecedent basis.
Regarding the use of “substantially” in claim 43-45. examiner maintains the 35 USC 112(b) rejection.
Regarding the 35 USC 112(d) rejection of claim 44 in view of claim 27, the rejection is withdrawn, but examiner will issue a warning that should claim 27 be found allowable, claim 44 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof.
With respect to the 35 USC 103 rejections of claim(s) 1, 2, 3, 19, 22, 23, 30, 32, 33, and 37, Examiner does not agree with Applicant’s argument that Holmstrom (US20100240010A1) would not be obvious to use as a skull bone fixture, but in order to advance prosecution, the rejection has been withdrawn. A new ground(s) of rejection is made in view of Westerkull (US20060093175A1) in view of Holmstrom (US20100240010A1).
Claim Objections
Claims 25, 42, 45, 52 and 54 are objected to because of the following informalities:
Claim 25 states “the screw thread” in line 2, but should read --the thread-- or all other instances of “thread” should read --screw thread-- to maintain consistency and avoid confusion. Claim 1 does recite “a screw thread” but dependent claims 2, 18, 20, 21, 24, 28, 30, 33, 35, 37-40, 42, 45, 47, and 50 recite “the thread”. No other dependent claim recites “the screw thread”. Examiner is objecting to the lack of consistency in using “the screw thread” vs “the thread” in the dependent claims.
Claims 42 and 45 recite “the thread of a first sub-section” and “the thread of a second sub-section”. The sub-sections were not previously presented, so the threads of the sub-sections were not previously presented, as such, the threads lack antecedent basis. The claims should recite --a thread of a first sub-section-- and --a thread of a second sub-section--.
Applicant is advised that should claim 27 be found allowable, claim 44 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
Claim 52, line 3 states “he same handed” but should read --the same handed--.
Claim 54, line 2 states “a bone conduction implant” but should read --the bone conduction implant-- to clarify it is the same implant of claim 1.
Appropriate correction is required.
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 27, 43-45 and 55 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 27, line 5 recites “the longitudinal axis” but it is unclear if it is referencing “a longitudinal axis of the bone fixture” at lines 2-3 or “a longitudinal axis of the fixture through the at least one cutting pocket” at lines 3-4, which renders the claim indefinite.
The term “substantially” in claims 43-45 is a relative term which renders the claim indefinite. The term “substantially” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Examiner interprets the use of substantially as the absolute value of each value, wherein “substantially different” is different, “substantially straight” is straight, and “substantially parallel” is parallel.
Claim 55, lines 2-3 recites “which outer portion extends about a longitudinal axis” but it is unclear what is in intended from the limitation.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-3, 22-23, 25-26, 30, 33, 35, 49, 51, and 53-55 are rejected under 35 U.S.C. 103 as being unpatentable over Westerkull (US20060093175A1) and further in view of Holmstrom (US20100240010A1).
Regarding claim 1, Westerkull discloses an apparatus for a bone conduction implant (Abstract), comprising a bone fixture (Figure 1, hearing aid anchoring fixture “104”) including a screw thread (Figure 2, threaded portion “110”) configured to screw into a skull (Figure 1, skull bone “106”), wherein at least a portion of the screw thread includes a structure the improves the osseointegration (Paragraph [0027]) when the apparatus for a bone conduction implant is implanted in the recipient's skull bone (Paragraph [0027]).
Westerkull does not explicitly disclose a structure configured to promote growth of a recipient's
skull bone. Holmstrom discloses a bone fixture (Holmstrom, Abstract “a fixture for insertion into a human bone”) including a screw thread configured to screw into bone tissue (Holmstrom, Figures 1-9, Paragraph [0031]) wherein the screw thread includes a structure configured to promote growth of the recipient's skull bone (Holmstrom, Paragraph [0006]). If a POSITA was looking to improve the osseointegration of Westerkull, they would look to the bone fixture of Holmstrom which actively stimulates the ingrowth of bone tissue, therefore it would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the apparatus as taught by Westerkull, with the bone fixture as taught by Holmstrom, since such a modification would provide the predictable results of actively stimulating the ingrowth of bone tissue (Holmstrom, Paragraph [0006]) resulting in osseointegration.
Regarding claim 2, Holmstrom further discloses the structure of the bone fixture is located at least at a crest of the thread and runs coincident with the crest of the thread. (Holmstrom, Figures 5a and 5b exemplify this as the bone growth promoting structures can be seen at least on the crest of the thread and as the structures exist along the thread they can be interpreted as running coincident with the crest of the thread).
Regarding claim 3, Holmstrom further discloses the bone fixture is a monolithic component that includes the structure (Holmstrom, Figures 1 and 6. The cross-section view of Figure 1 shows a single material and figure 6 shows that the driver and structure of the fixture is one piece. Further Holmstrom does not disclose the use of an osteopromotive layer, and only relies on the use of the structure design to improve bone growth.)
Regarding claim 22, Holmstrom further discloses the structure of the bone fixture is a patterned microstructure (Holmstrom, Figure 5, Paragraph [0079] “FIG. Sa illustrates a fixture 510 according to at least a fifth example embodiment of the invention. In the enlarged cut-out portion of FIG. Sa, it can be seen that a plurality of channels 530a, 530b are provided in a grid-like tight pattern, such that only pyramidal peaks 560 are formed on the flank surface.”).
Regarding claim 23, Holmstrom further discloses at least one of a depth or a pitch of thread(s) of a first sub-section of the bone fixture is different from that of a second sub-section (Holmstrom, Figures 8 and 9, sections “812” and “912” have a smaller depth than the lower section of the fixture).
Regarding claims 25 and 26, the bone fixture of Holmstrom is silent as to the screw thread establishes a threaded section and a first sub-section of the threaded section is tapered in an opposite direction from a second sub-section of the threaded section. Westerkull discloses the threaded section 110 includes a first subsection that is tapered in an opposite direction to a second subsection and a third subsection. The third subsection has an angle of taper relative to a longitudinal axis of the bone fixture that is greater than an angle of taper of the second sub-section (Westerkull, see annotated fig. 2 below, angles of first, second, and third subsections indicated by lines 1-3 added by the examiner). Westerkull states the that the distinct thread design provides many advantages both biomechanically and from an osseointegration perspective (Westerkull, [0014-0019]). It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the bone fixture of the apparatus as taught by modified Westerkull, with the thread design as taught by Westerkull, since such a modification would improve the biomechanical and osseointegration properties of Holmstrom’s fixture (Westerkull, [0014-0019]).
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Regarding claim 30, Holmstrom further discloses the structure of the bone fixture is located at least at a trough of the thread (Holmstrom, Figures 5a and 5b exemplify this as the bone growth promoting structures can be seen at least at a trough of the thread and as the structures exist along the trough they can be interpreted as running coincident with the thread).
Regarding claim 33, Holmstrom discloses the groove may form spirals around the longitudinal axis of the fixture or at a somewhat inclined direction or parallel to the longitudinal axis of the fixture (Holmstrom, [0068]). A spiral groove constitutes a groove running in a wave form to the thread direction. A groove inclined or parallel to the longitudinal axis of the fixture constitutes a spline form groove relative to the thread direction since such a groove would traverse the threads.
Regarding claim 35, the bone fixture of Holmstrom is silent on the angle of the threads, but Westerkull teaches the thread angle of the section is established by two faces both extending at respective acute angles from a plane normal through a centerline of the thread section (Westerkull, Figure 2, upper and lower faces of the thread are angled at an acute angle relative to a vertical plane through the threaded section). It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the bone fixture of the apparatus as taught by modified Westerkull, with the thread design as taught by Westerkull, since such a modification would improve the biomechanical and osseointegration properties of Holmstrom’s fixture (Westerkull, [0014-0019]).
Regarding claim 49, Westerkull, as modified in claim 1, discloses with respect to a view of the bone fixture looking laterally at the bone fixture, one side of the bone fixture has seven or less thread crests (Westerkull, Figure 2). As such the number of thread crests is a design consideration that will depend on the size of the fixture, as well as the depth of insertion and amount of osseointegration desired; the number of thread crests can be optimized based on the intended use and placement of the screw and Applicant has not disclosed the number of thread crests specifically as critical, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the apparatus as taught by modified Westerkull, by configuring the fixture of Holmstrom so one side of the bone fixture has seven or less thread crests as taught by Westerkull, as the number of crests would be optimized based on the intended use.
Regarding claim 51, Westerkull, as modified in claim 1, further discloses the apparatus is located totally beneath skin of the recipient (Westerkull, Figure 1, Paragraph [0006], the abutment must penetrate the skin in order to screw into the apparatus).
Regarding claim 53, Westerkull, as modified in claim 1, further discloses an abutment is attached to the bone fixture (Westerkull, Figure 1, abutment “102”).
Regarding claim 54, Holmstrom discloses the bone fixture may have a length in the range of 5-19 mm (Holmstrom, [0041]). As the apparatus, as disclosed supra, comprises the bone fixture (there may be additional components not disclosed), if the bone fixture had a length of 15 mm, the apparatus at a minimum, would have a length of 15 mm.
Regarding claim 55, Westerkull, as modified in claim 1, discloses the bone fixture includes an outer portion that is not threaded, which outer portion extends about a longitudinal axis of the bone fixture (Westerkull, see annotated Figure 2 below). As leaving a section of the fixture unthreaded is a design consideration that will depend on the size of the fixture, as well as the depth of insertion and amount of osseointegration desired; the totality of threading can be optimized based on the intended use and placement of the screw and Applicant has not disclosed leaving a section of the fixture unthreaded specifically as critical, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the apparatus as taught by modified Westerkull, by configuring the fixture of Holmstrom so the fixture includes an outer portion that is not threaded, wherein the outer portion extends about a longitudinal axis of the fixture as taught by Westerkull, as the unthreaded section would be optimized based on the intended use.
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Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Westerkull (US20060093175A1) in view Holmstrom (US20100240010A1), as applied to claim 1 above, and further in view of Tiainen (US20150223938A1).
Regarding claim 18, Westerkull, as modified in claim 1, discloses the structure is located at least at a crest of the thread (Holmstrom, Figures 1-5b exemplify this as the bone growth promoting structures can be seen at least on the crest of the thread), but fails to disclose the structure is a porous-solid scaffold. Tiainen teaches it is known in the art that using titanium dioxide porous scaffolds in bone fixtures (Tiainen, [0058]), which stimulate and guide the natural bone regeneration (Tiainen, [0010]), while maintaining the strength of titanium (Tiainen, [0014]) during formation of the scaffold. As Tiainen discloses the use of porous scaffold for bone fixtures to improve bone regeneration, it would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the apparatus as taught by modified Westerkull, with porous scaffolds as taught by Tiainen, since such a modification would provide alternative structure to the bone fixture disclosed by Holmstrom that has proven bone regeneration properties and also allows the titanium fixture to maintain its material strength, improving the performance of the fixture.
Claims 20-21 are rejected under 35 U.S.C. 103 as being unpatentable over Westerkull (US20060093175A1) in view Holmstrom (US20100240010A1), as applied to claim 1 above, and further in view of Giorno (US20110195380A1).
Regarding claims 20 and 21, Westerkull, as modified in claim 1, further discloses a cutting edge (Holmstrom, Paragraph [0066]), but fails to disclose the cutting edge is a helical grove that forms a spiral cutting edge having an opposite direction of the screw thread. Giorno discloses a self-tapping screw bone implant with two helical grooves running in opposite directions around the implant (Giorno, Paragraph [0002]) and the helical thread maybe right or left handed and contains at least one cutting edge for each turn of the cutting head. The implant further comprises a second helix running in the opposite direction of the helical thread (Giorno, Paragraph [0036]). Finally, Giorno discloses that the implants of the present design can be used in dental, surgical, hearing aid applications or any application where a stable support is required in bone (Giorno, Paragraph [0037]). It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the fixture of the apparatus as taught by modified Westerkull, with the opposite running helical grooves where one of the grooves functions as a cutting edge as taught by Giorno, since such a modification would provide the predictable results of allowing Holmstrom to maintain its osteopromotive characteristics while adding a second helical groove to improve the efficiency of delivering the implant (Giorno, Paragraph [0034]).
Claims 24 and 40 are rejected under 35 U.S.C. 103 as being unpatentable over Westerkull (US20060093175A1) in view Holmstrom (US20100240010A1), as applied to claim 1 above, and further in view of Branemark (US20080125868A1).
Regarding claims 24 and 40, Westerkull, as modified in claim 1, is silent as to a roughened surface limited to roots of the thread. However, Branemark discloses a bone implant fixture including a roughened surface, 4, 5, 6, 7 limited to roots 8 of the thread (Branemark, Figures 1-3, [0024 and 0047]; note: elements 6 and 8 appear to have been swapped in fig. 1). The roughened surface is configured to promote bone growth and is located at least four root turns of the thread (Branemark, Figures 1 and 8-9). The remaining portions of the fixture are not coated and are thus considered to be smooth (titanium ground surface) (Branemark, [0047]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include a roughened surface limited to roots of the thread on the fixture of the apparatus of modified Westerkull, in order to promote bone growth between the implant and patient tissue, while eliminating the problems that normally appear with rough implant surfaces by limiting the roughened portions to the roots of the thread, as taught by Branemark (Branemark, [0028] and [0047]) applying to the roots has been found to be advantageous).
Claims 27, 29, 41 and 44 is/are rejected under 35 U.S.C. 103 as being unpatentable over Westerkull (US20060093175A1) in view Holmstrom (US20100240010A1), as applied to claim 1 above, and further in view of Berckmans (US7771774B2).
Regarding claims 27 and 44, Westerkull, as disclosed in claim 1, discloses the cutting pockets extending across at least a portion of four threads (Holmstrom, Figure 1) but does not explicitly disclose the at least one cutting pocket extends across four thread crests and does not illustrate a cross-section of the fixture through the cutting pocket. Berckmans discloses a self-tapping bone screw with a plurality of cutting pockets 17 extending across at least four thread crests (Berckmans, Figures 1, 2a, 3a, 4a, and 6). Berckmans further discloses a cross-section taken parallel to a longitudinal axis of the fixture through the cutting pocket has a straight boundary portion parallel to the longitudinal axis, the straight boundary portion being established by the cutting pocket (Berckmans, Figures 2a, 2b, 3a, 3b, and 4a). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the apparatus as taught by modified Westerkull, by configuring the cutting pocket of Holmstrom to extend across at least four thread crests, as taught by Berckmans, as such a feature is a design consideration that will depend on the size of the fixture, as well as the size of the threads and the depth of insertion and amount of osseointegration desired; such features can be optimized based on the intended use and placement of the screw and Applicant has not disclosed extension across four thread crests specifically as critical (Paragraph [0076] of Applicant’s specification discloses the cutting pockets can extend across one, two, three, four, five, six or more thread crests or any value or range of values therebetween in integer increments). Furthermore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the apparatus as taught by modified Westerkull, by creating the cutting pocket of Holmstrom so as to define a straight boundary portion of a cross-section taken parallel to a longitudinal axis of the fixture through the cutting pocket since Berckmans discloses such cutting pockets are suitable for allowing the implant to be installed without a bone tap (Berckmans, Col. 3, lines 46-55) and thus would be expected to carry out the required functions of the cutting pocket of Holmstrom.
Regarding claim 29, Westerkull, as disclosed in claim 1, discloses at least one cutting pocket extending across a plurality of thread crests (Holmstrom, Figure 1) but is silent as to the cutting pocket including one structural surface feature configured to promote growth of the recipient’s skull bone. Furthermore, while Holmstrom illustrates the cutting pockets extending across at least a portion of four threads (Holmstrom, Figure 1), Holmstrom does not explicitly disclose the cutting pocket extends across four thread crests. However, Berckmans discloses a self-tapping bone screw with a plurality of cutting pockets 17 extending across at least four thread crests (Berckmans, Figures 1, 2a, 3a, 4a, and 6). Berckmans further discloses the surface of the screw, including the cutting pockets, is roughened and/or provided with a coating to promote bone growth (Berckmans, Figure 6 and Col. 4, lines 30-39). The coating may be applied without first roughening the surface of the implant (Berckmans, Col. 7, lines 16-21). A coating on an underlying smooth surface constitutes only one structural surface feature. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the apparatus as taught by modified Westerkull, by including only one structural surface feature to promote bone growth within the cutting pockets of Holmstrom, such as the coating on a smooth surface taught by Berckmans, in order to enhance osseointegration. In combination with Westerkull, such a feature will promote growth of the skull bone since the fixture is meant to be inserted into the skull. Furthermore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the apparatus as taught by modified Westerkull, by configuring the at least one cutting pocket of Holmstrom to extend across at least four thread crests, as taught by Berckmans, as such a feature is a design consideration that will depend on the size of the fixture, as well as the size of the threads and the depth of insertion and amount of osseointegration desired; such features can be optimized based on the intended use and placement of the screw and Applicant has not disclosed extension across four thread crests specifically as critical (Paragraph [0076] of Applicant’s specification discloses the cutting pockets can extend across one, two, three, four, five, six or more thread crests or any value or range of values therebetween in integer increments).
Regarding claim 41, Westerkull, as modified in claim 1, discloses at least one cutting pocket extending across a plurality of thread crests (Holmstrom, Figure 1). Holmstrom is silent as to the cutting pocket including only one or at least two structural surface features configured to promote growth of the recipient’s skull bone. However, Berckmans discloses a self-tapping bone screw with a plurality of cutting pockets 17 (Berckmans, Figures 1, 2a, 3a, 4a, and 6). The surface of the screw, including the cutting pockets, is roughened and provided with a coating to promote bone growth (Berckmans, Figure 6 and col. 4, lines 30-39). A coating combined with a roughened surface defines at least two structural surface features. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the apparatus as taught by modified Westerkull, by including at least two structural surface features to promote bone growth within the cutting pockets of Holmstrom, such as the roughened surface and coating taught by Berckmans, in order to enhance osseointegration. In combination with Westerkull, such a feature will promote growth of the skull bone since the fixture is meant to be inserted into the skull.
Claim 28 is rejected under 35 U.S.C. 103 as being unpatentable over Westerkull (US20060093175A1) in view Holmstrom (US20100240010A1), as applied to claim 1 above, and further in view of Day (US6102703A, hereinafter Day ‘703) and Branemark.
Regarding claim 28, Westerkull, as modified in claim 1, discloses at least one cutting pocket extending across a plurality of thread crests relative to a longitudinal axis of the bone fixture (Holmstrom, Figure 1) but is silent as to the cutting pocket extending across at least six thread crests and including a roughened surface configured to promote bone growth. However, Day ‘703 discloses a bone fixture comprising at least one cutting pocket extending across at least six thread crests of the fixture (Day ‘703, Figure 1). Day ‘703 further discloses application of a roughened surface (hydroxyapatite (HA) coating) to the outer surface of a bone fixture, including a middle portion 16 and distal portion 18 including the at least one cutting pocket (Day ‘703, Col. 4, lines 58-64 and Col. 5, lines 13-26). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the apparatus as taught by modified Westerkull, by configuring the cutting pockets of Holmstrom to extend across at least six thread crests, as taught by Day ‘703 as such a feature is a design consideration that will depend on the size of the fixture, as well as the size of the threads and the depth of insertion and amount of osseointegration desired; such features can be optimized based on the intended use and placement of the screw and Applicant has not disclosed extension across at least six thread crests as critical (Paragraph [0076] of Applicant’s specification discloses the cutting pockets can extend across one, two, three, four, five, six or more thread crests or any value or range of values therebetween in integer increments). It also would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the apparatus as taught by modified Westerkull, by applying a roughened portion to the at least one cutting pocket of the fixture of Holmstrom in order to promote osseointegration, as taught by Day ‘703 (Day ‘703, col. 2, lines 40-51).
Modified Westerkull, further modified by Day, discloses a roughened surface on a threaded portion of the fixture but is silent as to a roughened portion limited to roots of the thread and being located along at least four root threads. However, Branemark discloses a bone implant fixture including a roughened surface, 4, 5, 6, 7 limited to roots/valleys 8 of the thread (Branemark, Figures 1-3, [0024 and 0047]; note: elements 6 and 8 appear to have been swapped in figure 1) applied by sputter coating with a mask to achieve a desired pattern (Branemark [0048-52]). The roughened surface is configured to promote bone growth and is located at least four root turns of the thread (Branemark, Figures 1 and 8-9). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the apparatus as taught by modified Westerkull, by modifying the fixture disclosed by Holmstrom in view of Day ‘703 such that the a roughened portion is limited to roots of the thread (and possibly inner portions of the cutting pockets) in order to promote bone growth between the implant and patient tissue while eliminating the problems that normally appear with rough implant surfaces, as taught by Branemark (Branemark, [0028] and [0047] applying to the roots has been found to be advantageous).
Claim 34 is/are rejected under 35 U.S.C. 103 as being unpatentable over Westerkull (US20060093175A1) in view Holmstrom (US20100240010A1), as applied to claim 1 above, and further in view of Hansson (US20080091208A1).
Regarding claim 34, Westerkull, as modified in claim 1, is silent as to an outer circumference of the threaded section being non-circular and symmetric about two orthogonal planes which are each parallel to and lying on a longitudinal axis of the fixture. However, Hansson discloses a bone fixture having a threaded section with reduced portions 4 provided as sectors around the implant resulting in a non-circular cross-section or circumference of the threaded section (Hansson, Figure 3a and [0081-82]). The sectors can be 90 degree sections which are diametrically opposed (Hansson, [0043 and 0087]), thus defining a threaded section with four evenly distributed sectors. Such would result in an outer circumference of the threaded section being non-circular and symmetric about two orthogonal planes which are each parallel to and lying on a longitudinal axis of the fixture. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the apparatus as taught by modified Westerkull, by constructing the threaded portion of Holmstrom with a non-circular circumference having reduced portions symmetric about two orthogonal planes which are each parallel to and lying on a longitudinal axis of the fixture, because Hansson discloses such reduced portions allow for tissue ingrowth to occur during the first few weeks after implantation (Hansson, [0080]).
Claim 38 is rejected under 35 U.S.C. 103 as being unpatentable over Westerkull (US20060093175A1) in view Holmstrom (US20100240010A1), as applied to claim 1 above, and further in view of Bono (US6129730A).
Regarding claim 38, Westerkull, as modified in claim 1, is silent as to the thread section including a groove is located at a crest of the thread and the groove runs parallel to a thread direction of the thread. However, Bono discloses a bone screw including a threaded section “18” comprising a dual lead thread “19” with a groove “37” running parallel to the thread direction (Bono, Figures 3 and 4, col. 3, lines 39-46). The groove “37” of Bono is located at a crest of the thread and the groove runs parallel to the thread (Bono, Figures 3 and 4). Such a groove defines a crest different from a uniform curved truncated crest (which is interpreted as uniform smooth curved crest without a groove). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the apparatus as taught by modified Westerkull, by including a groove running parallel to the thread direction on the thread section of Holmstrom in order to increase pullout resistance, as taught by Bono (Bono, Col. 1, lines 26-39).
Claims 39 and 52 are rejected under 35 U.S.C. 103 as being unpatentable over Westerkull (US20060093175A1) in view Holmstrom (US20100240010A1), as applied to claim 1 above, and further in view of Hsieh (US20100092920A1).
Regarding claim 39, Westerkull, as modified in claim 1, is silent as to the thread section including a groove located at a root of the thread and running parallel to the thread. However, Hsieh discloses a bone screw implant with a threaded section and a groove located at a root of the thread that runs parallel to the thread (Hsieh, Figures 1 and 4, grooves 61 and 62 define the root 311 of thread 31 [0033]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the apparatus as taught by modified Westerkull, by including a groove located at the root portion and running parallel to the thread in the fixture of Holmstrom, in order to increase security of the implant in bone and increase the contact area with bone, as taught by Hsieh (Hsieh, [0019]).
Regarding claim 52, Westerkull, as modified in claim 1, discloses the screw thread is a first thread (Westerkull, Figure 2), but fails to disclose the screw thread includes a second thread that is the same handed direction as the first thread. Hsieh discloses bone fixture device (Hsieh, Paragraph [0007]) wherein the device comprises a multiplex thread structure with a twin helical thread structure comprising a first thread ”31” and a second thread “32” (Hsieh, Paragraph [0026], Figure 1). It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the apparatus as taught by Westerkull, by modifying the fixture of Holmstrom with a screw thread that includes a second thread that is the same handed direction as the first thread as taught by Hsieh, since such a modification would provide the predictable results of facilitating osseointegration (Hsieh, Paragraph [0027].
Claims 42, 43, and 45-47 are rejected under 35 U.S.C. 103 as being unpatentable over Westerkull (US20060093175A1) in view Holmstrom (US20100240010A1), as applied to claim 1 above, and further in view of Misch (US5628630A).
Regarding claim 42, Westerkull, as modified in claim 1, is silent as to the pitch of the threads of a first sub-section being different from that of a second sub-section. However, Misch discloses a bone screw implant comprising a threaded portion 40. The angle between an upper face edge 52 and a lower face edge 54 of the thread increases from an apex 36 of the implant to the crest 34 such that the pitch of the threads of a first sub-section differ from the pitch of the threads of a second sub-section (Misch, Figure 1 and col. 8, lines 20-36 and 44-46). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the apparatus as taught by modified Westerkull, by configuring the pitch of the threads of a first sub-section to differ from that of a second sub-section in the fixture of Holmstrom, similar to the configuration taught by Misch, in order to induce less strain in the crestal region of the bone, as Misch teaches stresses orthogonal to the occlusal plane are of greatest concern, especially in crestal regions, and the configuration of Misch provides increased surface area in the normal plane to the applied force in the crestal region which results in less strain applied to the crestal region (Misch, Col. 8, lines 26-43).
Regarding claim 43, Westerkull, as modified in claim 1, is silent as to the depth or the pitch of the threads of a first sub-section being substantially different from at least one of a depth or a pitch of a second sub-section. However, Misch discloses a bone screw implant comprising a threaded portion 40. The angle between an upper face edge 52 and a lower face edge 54 of the thread increases from an apex 36 of the implant to the crest 34 such that the pitch of the threads of a first sub-section differ substantially from the pitch of the threads of a second sub-section (Misch, Figure 1 and col. 8, lines 20-36 and 44-46). Misch further discloses the depth of the threads of the first sub-section are substantially different than the depth of the threads of the second sub-section (Misch, the radial length of the thread increases as the thread nears the crestal end 34 of core 32, core 32 narrows as it near the crestal end 34, col. 8, lines 49-56). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the apparatus as taught by modified Westerkull, by configuring the pitch or depth of the threads of a first sub-section to differ substantially from at least one of a depth or a pitch of a second sub-section in the fixture of Holmstrom, similar to the configuration taught by Misch, in order to induce less strain in the crestal region of the bone, as Misch teaches stresses orthogonal to the occlusal plane are of greatest concern, especially in crestal regions, and the configuration of Misch provides increased surface area in the normal plane to the applied force in the crestal region which results in less strain applied to the crestal region (Misch, Col. 8, lines 26-43 and 56-62).
Regarding claim 45, Westerkull, as modified in claim 1, is silent as to the pitch of the threads of a first sub-section being different from a pitch of the thread of a second sub-section while having the same handedness. However, Misch discloses a bone screw implant comprising a threaded portion 40. The angle between an upper face edge 52 and a lower face edge 54 of the thread increases from an apex 36 of the implant to the crest 34 such that the pitch of the threads of a first sub-section differ from the pitch of the threads of a second sub-section (Misch , Figure 1 and col. 8, lines 20-36 and 44-46) while the handedness of the threads is the same (Misch, Figure 1). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the apparatus as taught by modified Westerkull, by configuring the pitch of the threads of a first sub-section to differ from a pitch of the thread of a second sub-section while having the same handedness in the fixture of Holmstrom, similar to the configuration taught by Misch, in order to induce less strain in the crestal region of the bone, as Misch teaches stresses orthogonal to the occlusal plane are of greatest concern, especially in crestal regions, and the configuration of Misch provides increased surface area in the normal plane to the applied force in the crestal region which results in less strain applied to the crestal region (Misch, Col. 8, lines 26-43).
Regarding claim 46, Westerkull, as modified in claim 1, discloses a titanium apparatus for a bone conduction implant comprising a bone fixture including a screw thread configured to screw into a skull (Westerkull, Paragraph [0003]). Modified Westerkull is silent as to a depth and a pitch of threads of a first sub-section of the bone fixture are different from a depth and a pitch of thread(s) of a second sub-section, the second sub-section being lower relative to a longitudinal axis of the apparatus than the first sub-section. However, Misch discloses a bone screw implant comprising a threaded portion 40. The angle between an upper face edge 52 and a lower face edge 54 of the thread increases from an apex 36 of the implant to the crest 34 such that the pitch of the threads of a first sub-section differ from the pitch of the threads of a second sub-section (Misch, Figure 1 and col. 8, lines 20-36 and 44-46). Misch further discloses the depth of the threads of the first sub-section are substantially different than the depth of the threads of the second sub-section (Misch, the radial length of the thread increases as the thread nears the crestal end 34 of core 32, core 32 narrows as it near the crestal end 34, col. 8, lines 49-56). Misch further discloses the second sub-section being lower relative to a longitudinal axis of the apparatus than the first sub-section (Misch, see annotated fig. 1 below, “lower relative to the longitudinal axis” is interpreted as farther down the apparatus). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the apparatus as taught by modified Westerkull, by configuring the pitch or depth of the threads of a first sub-section to differ substantially from a depth and a pitch of thread(s) of a second sub-section in the fixture of Holmstrom, similar to the configuration taught by Misch, in order to induce less strain in the crestal region of the bone, as Misch teaches stresses orthogonal to the occlusal plane are of greatest concern, especially in crestal regions, and the configuration of Misch provides increased surface area in the normal plane to the applied force in the crestal region which results in less strain applied to the crestal region (Misch, Col. 8, lines 26-43 and 56-62).
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Regarding claim 47, modified Westerkull, as further modified by Misch, teach the limitations of claim 42 and Misch further discloses a thread angle of the thread of the first sub-section is different from a thread angle of the thread of the second sub-section (Misch, See annotated fig. 1 below).
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Conclusion
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/CHARLES A MARMOR II/Supervisory Patent Examiner
Art Unit 3791
/M.D.H./Examiner, Art Unit 3791