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 .
Drawings
The replacement drawings, filed 05/18/26, have been entered.
Claim Objections
Claim 10 is objected to because of the following informalities: In Lines 1-2, the words “configured to penetrate” should be deleted since the hole is a structural component of the screw and not a functional limitation. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 6-9 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 6 recites the limitations “wherein the shaft includes a shaft projection in the removal direction, and the shaft projection fits into a head recess of the head.” And Claim 1 previously recites a “the head includes a head projection in the insertion direction, and the head projection fits into a recess of the shaft”. Claim 6 seeks to introduce new matter as the specification describes one embodiment which has a head projection which fits into a recess of the shaft (as recited in Claim 1), and another non-depicted embodiment where the shaft includes a projection which fits into a recess of the head (as recited in Claim 6), but does not disclose an embodiment which incorporates both a head projection and a shaft projection, and a shaft recess and a head recess. Thus, it appears that the claims are reciting a combination of embodiments which there is no support for in the disclosure. It is suggested that Claim 1 be amended to recite both head/shaft connection arrangement limitations in an alternate recitation format, cancel the limitations from Claim 1, cancel Claim 6, or otherwise amend to delete the recitation of the combination of embodiments which do not have support in the disclosure. Appropriate correction is required.
Claim 8 has been newly amended (in the claims filed 05/18/26) to depend from Claim 6 and recites the limitation “further comprising: a core that includes at least one of metal, ceramic, cermet, and reinforced fibers of a composition different from the reinforced fibers, wherein the core fits into the head recess and the recess of the shaft recess.” which seeks to introduce new matter for the same reason stated above in Claim 6, and furthermore as the specification discloses an embodiment in which the head and the shaft are provided with recesses that a core part may fit into, but does not disclose an embodiment which incorporates both a head projection which fits into a shaft recess and a head recess, where a core fits into both the head recess and the shaft recess. As stated above in claim 6, it is suggested that Claim 1 be amended to recite all three head/shaft connection arrangement limitations in an alternate recitation format, cancel the limitations from Claim 1, cancel Claims 6 & 8, or otherwise amend to delete each recitation of the combination of embodiments which do not have support in the disclosure. 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 6-9 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 6 recites the limitations “wherein the shaft includes a shaft projection in the removal direction, and the shaft projection fits into a head recess of the head.” which renders the claim indefinite as it is unclear if the recited “head recess of the head” is in addition to the “head projection” which fits into “a recess of the shaft” as previously recited in Claim 1, or if the claim is intending to recite another arrangement in place of the head projection and shaft recess as recited in the specification. Appropriate correction is required.
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.
Claim(s) 1, 2, 4, 10-13, 15 & 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rocci et al. (US PG Pub No. 2020/0367951) in view of Globermann et al. (US PG Pub No. 2016/0113695).
Regarding Claims 1 & 15, Rocci discloses a bone screw (43, Figs. 6A-6D, Paragraphs [0017-20, 0058-0075]) comprising: a shaft (72, Fig. 6B or 6C), a tip (pointed distal tip of 72, Figs. 6B or 6C) located at a distal end of the shaft in an insertion direction (insertion direction is a direction from the distal tip toward bone) (“The distal tip can be self-tapping in some examples.”, Paragraph [0058]), a head (70, Fig. 6B or 6C) located at a proximal end of the shaft (77, Fig. 6C or 6C) in a removal direction (removal direction is a direction from the head toward the user), and a thread (69, Figs. 6A-6C) spirally located in an axial direction (formed about the outer surface of 72) (axial direction is a direction circumferentially about the longitudinal axis 52) around an outer circumference of the shaft (Paragraph [0058, 0074]), wherein the head includes a head projection (80, Fig. 6B, Paragraphs [0062-0063, 0065]) in the insertion direction (see arrow, Fig. 6B), and the head projection fits into a recess of the shaft (82, Fig. 6B, Paragraphs [0062-0063]).
Rocci et al. does not disclose wherein the head projection includes a mixture of metal at more than 0% and less than or equal to 30% by weight, combined with a composition that includes reinforced fibers. Rocci et al. does disclose in Paragraphs [0060-0061] that “the first and second portions 70 and 72 can each be made of any suitable alternative biocompatible material as desired, such as other titanium alloys, commercially pure titanium or stainless steel”, “In one example, the first portion 70 and the second portion 72 can be made from the same material”, “the first portion 70 can be made of a first material, and the second portion 72 can be made of a second different material having a material hardness less than that of the first material.”, and “Alternatively still, the first portion 70 can be made of a first material and the second portion 72 can be made of a second material having a material hardness greater than the first material.”
Globermann et al. discloses a cannulated, composite material screw (100A, Abstract, Figs. 1C & 4-5, Paragraphs [0063-0066, 0082]) comprising a cannulated shaft (101 with 108, Fig. 1C), a tip (distal most tip, Fig. 1C) at a distal end of the screw, and a head (105) at a proximal end of the screw, wherein an internal body (109) defining the screw comprises a composite material construction comprising carbon reinforcing fibers, for example CFR-PEEK and/or other materials added for radiopacity (Paragraphs [0009, 0052]), wherein "[0021] Use of a composite fiber constructed body potentially provides advantages (compared to an equivalent all-metal body) such as, for example, reduced stress shielding and lower imaging artifact incidence, optionally with strength that is about as high as all-metal equivalent, wherein “In some embodiments, radiopacity is added to a relatively radiolucent bone screw with a metallic layer by use of a particularly radiopaque material, for example, gold, platinum, rhenium, tungsten, tantalum, barium sulfate, and/or iodinated compounds. This potentially allows a relatively small amount of material to be used to achieve a comparatively greater radiopacity. Potentially, interference with other properties of the bone screw (mechanical strength, in particular), is reduced by this choice of materials for lending radiopacity to a screw. [0025] The distribution of radiopaque material is optionally to all or a part of the inner surface of the composite bone screw's outer layer. The radiopaque material is provided, for example, as a powder, grains, particles, foil, or in another form. Optionally, the radiopaque part is localized to one or more of the major structural regions of the screw (shaft, tip, and/or head, for example). Optionally, the radiopaque part is sparsely distributed as distinct concentrations of material in a region of the screw, covering, for example, about 1%, 5%, 10%, or another greater, lesser, or intermediate fraction of the surface in the region. Optionally, the radiopaque material is distributed in a pattern which identifies a structural feature of the bone screw and/or a limit of its extent. For example, the radiopacity is positioned to outline the screw shaft or a portion thereof, to identify a limit of the screw tip or head, and/or to identify an axial and/or rotational orientation of the screw." (Paragraphs [0021-0025]) Paragraph [0065] further states that “A bone screw 100A comprises a region 402 which is relatively radiopaque throughout a thickness near the surface of the bone screw. For example, an outer layer comprises a sheet or densely distributed powder of a radiopaque material such as gold, platinum, rhenium, tungsten, tantalum, barium sulfate, and/or iodinated compounds.” And Paragraph [0058] even further discloses “For example, the added radiopaque material can be selected largely based on its specific radiopacity as such, with a reduced importance of its surface or other structural properties. In some embodiments, materials in layer 152 have a relatively high specific radiopacity (high linear attenuation coefficient) and may include, for example, gold, platinum, rhenium, tungsten, tantalum, barium sulfate, and/or iodinated compounds. The radiopaque layer is optionally provided in any suitable form, for example, as a sheet, a deposited layer, powder, and/or discreet structures such as pellets and/or grains.”
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the screw head of Rocci et al. to be made from a CFR-PEEK material with a gold or tantalum powder distributed therewithin as taught by Globermann et al. in order to provide a bone screw with reduced stress shielding at the head thus reducing the likelihood of early implant failure and preserving bone integrity after implantation. Furthermore, it would have been obvious to provide the gold or tantalum powder at more than 0% and less than or equal to 30% by weight based on a desired specific radiopacity while reducing interference with mechanical or other properties of the screw since it has been held that where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. In re Aller, 105 USPQ 233.
Regarding Claim 2, the combination of Rocci et al. and Globermann et al. discloses the claimed invention as stated above in Claim 1, and Rocci et al. further discloses a portion between the head and the shaft (projection 80, Fig. 6B) that has a higher hardness compared to the shaft (“the second portion 72 can be made of a second different material having a material hardness less than that of the first material.” Paragraph [0061]).
Regarding Claim 4, the combination of Rocci et al. and Globermann et al. discloses the claimed invention as stated above in Claim 1, and Rocci et al. further discloses wherein the recess of the shaft (82, Fig. 6B) has a notch (tapered notch adjacent to the distal end of the recess 82).
Regarding Claim 10, the combination of Rocci et al. and Globermann et al. discloses the claimed invention as stated above in Claim 1, and Rocci et al. further discloses wherein the bone screw includes a hole (82, Fig. 6B or 6C) through the interior of the bone screw in the axial direction, wherein the hole is surrounded by a material that includes at least one of metal (CFR-PEEK material with a gold or tantalum powder distributed therewithin as taught by Globermann).
Regarding Claim 11, the combination of Rocci et al. and Globermann et al. discloses the claimed invention as stated above in Claim 1, and Rocci et al. further discloses wherein the tip includes a material that produces a higher brightness in medical imaging compared to the reinforced fibers (“the first portion 70 can be made of a first material and the second portion 72 can be made of a second material having a material hardness greater than the first material.” Paragraph [0061]).
Regarding Claims 12 & 13, the combination of Rocci et al. and Globermann et al. discloses the claimed invention as stated above in Claim 1, except wherein the reinforced fibers are arranged in a position spirally wound around the axial direction of at least one of the shaft and the thread, and wherein the reinforced fibers are arranged in the same direction as a spiral direction of the thread.
Globermann et al. discloses in Paragraphs [0009 & 0037] that the reinforcing fibers can be “helically wound in an opposite direction to a winding direction of the screw thread.” and “In some embodiments, the screw thread comprises reinforcing fibers helically wound in the same direction as the winding direction of the screw thread.”, wherein “the reinforcing fibers are arranged to withstand torque applied during unscrewing of the screw. Such a layer may include, for example, fibers arranged to match a profile of the screw thread. Additionally or alternatively, some embodiments comprise at least one layer in which the reinforcing fibers are arranged to withstand torque during screwing of the screw. Such a layer may include, for example, fibers arranged at a reverse direction to the screw thread. In an embodiment, the bone screw comprises a core including longitudinal fibers arranged along the screw axis, potentially resisting bending forces; a thread comprising fibers wound at a profile that matches the thread, potentially resisting torque such as torque applied during unscrewing of the screw; and a layer intermediate the screw core and the screw thread comprising fibers arranged at a direction opposite the thread winding direction, potentially resisting torque such as torque applied during screwing of the screw.” (Paragraph [0037]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the arrangement of the reinforcing fibers of the screw of the combination such that the fibers are helically wound in an opposite direction to a winding direction of the screw thread or helically wound in the same direction as the winding direction of the screw thread as taught by Globermann et al. in order to help resist torque applied during screwing or unscrewing of the screw.
Regarding Claim 16, the combination of Rocci et al. and Globermann et al. discloses the claimed invention as stated above in Claim 1, except wherein at least one of the shaft, the tip, and the thread includes a mixture of metal at more than 0% and less than or equal to 30% by weight, combined with a composition that includes the reinforced fibers. Rocci et al. does disclose in Paragraphs [0060-0061] that “In one example, the first portion 70 and the second portion 72 can be made from the same material”. Thus, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the shaft of the screw of the combination to also be made from a CFR-PEEK material with a gold or tantalum powder distributed therewithin as taught by Globermann et al. in order to provide a bone screw which has strength similar to an all-metal equivalent while lower imaging artifact incidence. Furthermore, it would have been obvious to provide the gold or tantalum powder at more than 0% and less than or equal to 30% by weight based on a desired specific radiopacity while reducing interference with mechanical or other properties of the screw since it has been held that where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. In re Aller, 105 USPQ 233.
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rocci et al. (US PG Pub No. 2020/0367951) in view of Globermann et al. (US PG Pub No. 2016/0113695) as applied to Claim 1 above and further in view of Tsuchida et al. (US PG Pub No. 2021/0025428).
Regarding Claim 14, the combination of Rocci et al. and Globermann et al. discloses the claimed invention as stated above in claim 1, except wherein the reinforced fibers are bent within the thread.
Tsuchida et al. discloses a fastener (1, Figs. 5a-5c, Paragraphs [0062-0067]) including reinforced fibers (reinforcing fiber 12, Paragraph [0045]), comprising: a shaft (30, Fig. 5a), a tip (distal most end portion of 30, Fig. 5a) located at a distal end of the shaft (end opposite head 31, Fig. 5a) in an insertion direction (insertion direction is the tip first direction the screw enters a substrate), a head (31, Fig. 5a, Paragraph [0062]) located at a proximal end of the shaft (via 32, Fig. 5a) in a removal direction (removal direction is the opposite direction from the insertion direction, and the direction in which the screw is withdrawn head first from a substrate), and a thread (threads extending along 30, not labeled in Fig. 5a-5c) extending in an axial direction around an outer circumference of the shaft (Figs. 5b-5c, Paragraph [0029, 0062-0063]), wherein reinforced fibers are arranged along the axial direction of the shaft (CFRP layer 70, Paragraphs [0063-0065], Figs. 5b-5c) and wherein the reinforced fibers are bent within the thread (Paragraphs [0016-0017, 0026]). Paragraph [0026] discloses “The method for manufacturing a fiber-reinforced resin bolt according to Application Example 3 includes, after the winding step, a bending step of bending the reinforcing fiber tape layer (60) formed by the winding step with respect to an axis parallel to the winding axis. The resin injection step includes placing the reinforcing fiber tape layer (60) formed by the bending step in a die (40) whose inner wall surface is formed with a screw shape, and injecting a resin into the die (40) in which the reinforcing fiber tape layer (60) is placed.”
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the arrangement of the reinforcing fibers of the screw of the combination such that the fibers are bent within the thread as taught by Tsuchida et al. as an alternate and functionally equivalent fiber arrangement which would further increase strength in the threaded portion of the shaft.
Claim(s) 17 & 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rocci et al. (US PG Pub No. 2020/0367951) in view of Globermann et al. (US PG Pub No. 2016/0113695) as applied to Claim 1 above and further in view of Zang et al. (US PG Pub No. 2005/0177165).
Regarding Claims 17 & 19, the combination of Rocci et al. and Globermann et al. discloses the claimed invention as stated above in claim 1, except wherein an angle of the thread is between 60 degrees and 80 degrees, and wherein the flank angle of the thread in the insertion direction is larger than the flank angle of the thread in the removal direction.
Zang et al. discloses a screw (Figs. 1A-1C) comprising an externally threaded shaft (14, Fig. 1A), wherein a thread angle (50) of the screw “may be between approximately 45 and 75 degrees” or as shown in Fig. 1A, the thread angle 50 is approximately 60 degrees, (Paragraph [0021]), and wherein the flank angle of the thread in the insertion direction (leading flank 24, Paragraph [0016], Fig. 1B) is larger than the flank angle of the thread in the removal direction (trailing flank 26, Fig. 1B). Zang et al. teaches that the dimensions defining the threads may be selected based on a number of objectives such as to provide a screw which may be easily threaded and adequately secured in place.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the thread of the screw of the combination such that the angle of the thread is 60 degrees as taught by Zang et al. and such that the flank angle of the thread in the insertion direction is larger than the flank angle of the thread in the removal direction as taught by Zang et al. in order to allow the screw to be easily threaded into a substrate and more adequately secured in place after insertion therein.
Claim(s) 18 & 20-22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rocci et al. (US PG Pub No. 2020/0367951) in view of Globermann et al. (US PG Pub No. 2016/0113695) as applied to Claim 1 above and further in view of Lasner (US Patent No. 5,120,171).
Regarding Claims 18 & 20-22, the combination of Rocci et al. and Globermann et al. discloses the claimed invention as stated above in Claim 1, except wherein an angle of the thread increases in the insertion direction within a range of 60 degrees to 80 degrees, wherein a height of the thread increases in the insertion direction, wherein the axial length of the crest of the thread decreases in the insertion direction, and wherein the pitch of the thread increases in the insertion direction.
Lasner discloses a screw with improved threads (Abstract, 10, Figs. 1-3) comprising an externally threaded shaft (13/12), a head (11) at a proximal end of the screw, and a tip (14) at a distal end of the screw, wherein the angle of the thread increases in the insertion direction (Fig. 2), wherein the height of the thread increases in the insertion direction (Fig. 1), wherein the axial length of the crest of the thread decreases in the insertion direction (Fig. 1), and wherein the pitch of the thread increases in the insertion direction (Fig. 1-2). Lasner does not disclose that the angle of the thread increases within a range of 60 degrees to 80 degrees, however it appears the angle of the thread is within this range.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the thread of the shaft of the combination so that the angle of the thread increases in the insertion direction, the height of the thread increases in the insertion direction, the axial length of the crest of the thread decreases in the insertion direction, and the pitch of the thread increases in the insertion direction as taught by Lasner in order to enhance the pull out resistance of the screw from its position after insertion into a substrate. Furthermore, it would have been obvious to have the angle of the thread increasing in the insertion direction within a range of 60 degrees to 80 degrees since it has been held that where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. In re Aller, 105 USPQ 233.
Response to Arguments
The replacement drawings, filed 05/18/26, have overcome the drawing objection.
Applicant’s amendments, filed 05/18/26, have overcome the objection to claim 10.
Applicant’s amendments, filed 05/18/26, have overcome the 112(b) rejections for claims 1, 8, 13, 16, 17, 18 & 20.
In regards to Applicant’s arguments, filed 05/18/26, with respect to the 102 rejection of Claims 1 & 12-15 as anticipated by Tsuchida et al. and the remaining claims rejected under 35 USC 103: The Applicant’s arguments have been fully considered but are moot in view of the new grounds of rejection based on the newly amended claims.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JESSICA WEISS whose telephone number is (571) 270-5597. The examiner can normally be reached Monday through Friday, 8:00 am to 4:00 pm EST. If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, KEVIN T. TRUONG, at 571-272-4705. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/JESSICA WEISS/Primary Examiner, Art Unit 3775
Prosecution Insights