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 .
Claim Objections
Claim 1 is objected to because of the following informalities: In the last line of the claim, the words “the surface roughness” should be amended to --a surface roughness-- and the word “micrometres” should be replaced with the spelling --micrometers--. Appropriate correction is required.
Claim 6 is objected to because of the following informalities: In Line 4, the words “is configured as” should be replaced with the word --comprises--. Appropriate correction is required.
Claim 7 is objected to because of the following informalities: In Line 4, the words “is configured as” should be replaced with the word --comprises--. Appropriate correction is required.
Claim 10 is objected to because of the following informalities: In Line 3, the word “moulding” should be replaced with the spelling --molding--. Appropriate correction is required.
Claim 12 is objected to because of the following informalities:
In Line 6, the word “Aluminium” should be replaced with the spelling --Aluminum--.
In Line 7, the word “Niob” should be replaced with the spelling --Niobium--. Appropriate correction is required.
Claim 14 is objected to because of the following informalities: In Line 3, both instances of the word “micrometres” should be replaced with the spelling --micrometers--. Appropriate correction is required.
Claim 15 is objected to because of the following informalities: In Line 2, the words “a” and “component” before and after “monolithic” should be deleted. Appropriate correction is required.
Claim 16 is objected to because of the following informalities: In Line 3, the word “moulding” should be replaced with the spelling --molding--. 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 1-16 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 1 recites the limitation "the cannulation wall" in the last line. There is insufficient antecedent basis for this limitation in the claim. For purposes of examination, the limitation is being interpreted as --a wall of the central cannulation--. Appropriate correction is required.
Claim 5 recites the limitation “wherein the first cross-sectional area remains substantially constant over a first cannulation portion having a length 'L1' of at least 2 mm, or more specifically at least 5 mm.” which renders the claim indefinite as:
Firstly, regarding the limitation “wherein the first cross-sectional area remains substantially constant over a first cannulation portion having a length 'L1'”, it is unclear how a cross-sectional area at the shaft tip remains constant over a portion having a length, when area is a measurement of the total space inside a two dimensional surface, (specifically here being a circular opening/portion at the shaft tip). It appears from Fig. 1D that the cannulation portion has a length L1 which includes a constant diameter and for purposes of examination, the limitation is being interpreted as “wherein the shaft tip section comprises a cannulation portion having a length L1 of at least 2 mm and a constant diameter.”. Appropriate correction is required.
Secondly, regarding the limitation “having a length 'L1' of at least 2 mm, or more specifically at least 5 mm”, 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, the claim recites the broad recitation “at least 2 mm”, and the claim also recites “more specifically at least 5 mm” 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. For purposes of examination, the limitation is being interpreted as “at least 2 mm”. Appropriate correction is required.
Claim 8 recites the limitation “for engagement with an insertion tool, such as a screwdriver” which renders the claim indefinite as the term “such as” suggests an optional example and thus it is unclear if the screwdriver is required, making the scope of the invention ambiguous. For purposes of examination, the limitation is being interpreted as “for engagement with an insertion tool”. Appropriate correction is required.
Claim 14 at Lines 2-3 recites the limitation “wherein the surface roughness of the cannulation wall is at most 5 micrometres, or more preferably at most 1.6 micrometres.” 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, the claim recites the broad recitation “at most 5 micrometers”, and the claim also recites “or more preferably at most 1.6 micrometers” 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. For purposes of examination, the limitation is being interpreted as “at most 5 micrometers”. Appropriate correction is required.
Claim 16 at Line 3 recites the limitation “the bone fastener assembly”. There is insufficient antecedent basis for this limitation in the claim. For purposes of examination, the limitation is being interpreted as “the cannulated bone fastener”. 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) 1-8, 10 & 13-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Patel (US PG Pub No. 2021/0022873) in view of Martin et al. (US PG Pub No. 2018/0271573).
Regarding Claims 1 & 14 as best understood, Patel discloses a cannulated bone fastener (108, Figs. 4-9, Paragraphs [0071-0082]) for engagement into a target bone (Abstract, Paragraphs [0050-0054]), the cannulated bone fastener comprising an elongated shaft (120, Fig. 5) extending between a shaft tip section (distal section 122, Fig. 4) and a head section (proximal section 123, Fig. 4), a central cannulation (134, Fig. 5) having a cannulation entry (130, Fig. 5) with a first cross-sectional area (Fig. 8) at the shaft tip section, and a cannulation exit (132, Fig. 5) with a second cross-sectional area (Fig. 9) at the head section, wherein the first cross-sectional area is different from the second cross-sectional area (Fig. 5)(See examiner annotated Fig. 5 below).
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Patel does not disclose wherein a surface roughness of a wall of the central cannulation is at most 25 micrometers, or at most 5 micrometers. Patel does disclose that the channel 134 is for accepting a guidewire, and further discloses that the fastener is made from “titanium or tantalum metal or alloy with a similar modulus of elasticity”, but no specific surface roughness is disclosed for the channel 134. Furthermore, one having ordinary skill in the art would recognize that a surface roughness of titanium and tantalum or similar alloys is widely variable from ultra smooth to rough based on polishing, machining, specific manufacturing processes, per the desired application.
Martin et al. discloses devices and methods for repairing bone, wherein a metal orthopedic bone screw (100) is depicted in Fig. 1 “is fabricated from stainless steel and includes a shaft 101 with a shaft diameter 102 and a threaded portion 103 located at tip 109. The surface of shaft 101 is substantially smooth, having a surface roughness, Ra, of less than about 3 micrometers, where the surface roughness is measured parallel to the axis of shaft 101. The smooth shaft surface allows easy gliding of shaft 101 into entry hole 154, so that if humeral head 152 should collapse, shaft 101 slides out of entry hole 154 rather than being engaged therewith, which would force threaded portion 103 through cancellous bone 156.”
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the inner wall defining the central cannulation of the fastener of Patel to include a surface roughness less than 3 micrometers as taught by Martin et al. so that the inner wall defining the central cannulation is substantially smooth and allows the screw to more easily glide along the guidewire during a procedure.
Regarding Claim 2, the combination of Patel and Martin et al. discloses the claimed invention as stated above in claim 1, and Patel further discloses wherein the first cross-sectional area is smaller than the second cross-sectional area (See examiner annotated Fig. 5 above).
Regarding Claim 3, the combination of Patel and Martin et al. discloses the claimed invention as stated above in claim 1, and Patel further discloses wherein the first cross-sectional area is larger than the second cross-sectional area (See examiner annotated Fig. 5 above).
Regarding Claim 4, the combination of Patel and Martin et al. discloses the claimed invention as stated above in claim 1, and Patel further discloses wherein the elongated shaft comprises an external thread (140, Fig. 4, Paragraph [0056]).
Regarding Claim 5 as best understood, the combination of Patel and Martin et al. discloses the claimed invention as stated above in claim 1, and Patel further discloses wherein the shaft tip section comprises a cannulation portion having a length L1 and a constant diameter (See examiner annotated Fig. 5 above).
Patel does not disclose that the length L1 of the cannulation portion is at least 2 mm. However, Paragraph [0052] discloses that the implant has a diameter of 4mm to 14mm and a length from 10 mm to 280 mm. 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 length L1 of the cannulation portion of the shaft tip section to be at least 2 mm 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 6, the combination of Patel and Martin et al. discloses the claimed invention as stated above in claim 1, and Patel further discloses wherein the central cannulation comprises a transition section connecting the first cross-sectional area to the second cross-sectional area, and wherein the transition section comprises at least one diverging taper (See examiner annotated Fig. 5 above).
Regarding Claim 7, the combination of Patel and Martin et al. discloses the claimed invention as stated above in claim 1, and Patel further discloses wherein the central cannulation comprises a transition section connecting the first cross-sectional area to the second cross-sectional area, and wherein the transition section comprises at least one diverging curved transition (See examiner annotated Fig. 5 above)(transitions are curved as the cannulation is cylindrical).
Regarding Claim 8, the combination of Patel and Martin et al. discloses the claimed invention as stated above in claim 1, and Patel further discloses wherein the cannulated bone fastener further comprises a drive (screwdriver socket 152, Figs. 5-6 & 9) for engagement with an insertion tool (Paragraph [0074]).
Regarding Claim 10, the claimed phrase “manufactured by injection molding or additive manufacturing” is being treated as a product by process limitation. As set forth in MPEP 2113, product by process claims are not limited to the manipulation of the recited steps, only the structure implied by the steps. Once a product appearing to be substantially the same or similar is found, a 35 USC 102/103 rejection may be made and the burden is shifted to applicant to show an unobvious difference. MPEP 2113. The combination of Patel and Martin et al. discloses the claimed invention as stated above in claim 1, and Patel further discloses wherein the cannulated bone fastener is manufactured by additive manufacturing (Paragraphs [0079-0080]).
Regarding Claim 13, the combination of Patel and Martin et al. discloses the claimed invention as stated above in claim 1, and Patel further discloses wherein at least the shaft tip section comprises one or more openings (fenestrations 160, Figs. 4-7) leading to the central cannulation for injecting bone cement around the cannulated bone fastener (Paragraph [0071]).
Regarding Claim 15, the combination of Patel and Martin et al. discloses the claimed invention as stated above in claim 1, and Patel further discloses wherein the cannulated bone fastener is monolithic (Figs. 4-7).
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Patel (US PG Pub No. 2021/0022873) in view of Martin et al. (US PG Pub No. 2018/0271573) as applied to Claim 1 above and further in view of Richter (US PG Pub No. 2004/0267349).
Regarding Claim 9, the combination of Patel and Martin et al. discloses the cannulated bone fastener as stated above in claim 1, but Patel does not disclose wherein the cannulated bone fastener is made of an amorphous metal. Paragraphs [0019 & 0079-0080] of Patel do disclose that the implant is fabricated from a titanium or tantalum metal or alloy with a similar modulus of elasticity to the bone, wherein the titanium or tantalum metal or alloy is a porous material with pore sizes ranging in 100 to 900 micrometers and a porosity of 60-65%.
Richter discloses various medical devices and implants such as surgical fasteners made from amorphous metal alloys (Abstract), wherein “Amorphous metal alloys are suitable because of their high mechanical strength, resistance to in vivo oxidation and corrosion, and overall biocompatibility. The surgical fasteners may be made by heat extrusion methods described above. In certain embodiments, the surgical fastener of this invention consists of an amorphous metal article that can be directly implanted into a living creature. Alternatively, the surgical fastener may be combined with other components such as biodegradable polymers and/or therapeutic agents (e.g., thrombosis or fibrinolytic inhibitors) to promote healing.” (Paragraph [0036]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the fastener of the combination to be made from an amorphous metal as taught by Richter in order to provide the fastener with increased mechanical strength and bone-like elasticity, improved corrosion resistance, and better overall biocompatibility.
Claim(s) 11-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Patel (US PG Pub No. 2021/0022873) in view of Martin et al. (US PG Pub No. 2018/0271573) as applied to Claim 1 above and further in view of Richter (US PG Pub No. 2004/0267349) and Kusleika et al. (US PG Pub No. 2008/0125848).
Regarding Claims 11-12, the combination of Patel and Martin et al. discloses the cannulated bone fastener as stated above in claim 1, but Patel does not disclose
wherein the cannulated bone fastener has a chemical composition, given as a weight percentage, comprising: a. Zirconium (Zr): balance; b. Copper (Cu): 16% plus/minus 5%;c. Nickel (Ni): 12% plus/minus 5%; and d. Titanium (Ti): 3% plus 5%, minus 2%; and wherein the cannulated bone fastener has a chemical composition, given as a weight percentage, comprising: a. Zirconium (Zr): Balance; b. Copper (Cu): 24% plus/minus 5%;c. Aluminum (Al): 4% plus 5%, minus 2%; and d. Niobium (Nb): 2% plus 5%, minus 1%.
Richter discloses various medical devices and implants such as surgical fasteners made from amorphous metal alloys (Abstract), wherein “Amorphous metal alloys are suitable because of their high mechanical strength, resistance to in vivo oxidation and corrosion, and overall biocompatibility. The surgical fasteners may be made by heat extrusion methods described above. In certain embodiments, the surgical fastener of this invention consists of an amorphous metal article that can be directly implanted into a living creature. Alternatively, the surgical fastener may be combined with other components such as biodegradable polymers and/or therapeutic agents (e.g., thrombosis or fibrinolytic inhibitors) to promote healing.” (Paragraph [0036]).
Kusleika et al. discloses medical devices and implants made from amorphous metals or alloys (Abstract), wherein “[0146] The particular metal or alloy which is used in any of the amorphous metal structures depends upon the intended use and desired functions of the medical device. In certain embodiments, the amorphous metal is chosen for its biocompatibility in the intended application. In some embodiments, the amorphous metal is a bulk solidifying amorphous alloy. For instance, the amorphous metal can be stainless steel, alloys of nickel and titanium similar to nitinol, alloys of zirconium and/or titanium, ELGILOY, HASTELLOY, INCOLOY, alloys of cobalt and chromium, bioabsorbable metals such as magnesium alloys, radiopaque materials such as gold or platinum, etc. Certain amorphous metals may be an alloy including one or more metals selected from zirconium, titanium, nickel, copper, iron, beryllium, aluminum, silicon, niobium, copper, nickel. Other transition metals may also be included in some embodiments. One can alternatively select other alloys that cannot be easily processed in crystalline form. In some embodiments, the metal/alloy is solidified at a sufficiently fast rate and under conditions such that the formation of a crystalline or granular structure in the solid form of the metal/alloy is inhibited. Radiopaque crystalline materials may be also used in combination with the amorphous metal, or the amorphous metal may be coated with radiopaque markings, as desired for the intended imaging of the internally deployed medical device.” Furthermore “[0086] Shape setting of amorphous alloys can be advantageous for applications in medical devices. A commonly used metal in medical devices which can be shape set is nitinol, in one variation a roughly equiatomic alloy of nickel and titanium. While nitinol alloys are widely used for medical devices, these alloys have certain limitations. They are hard to join to themselves and to other materials because application of heat can compromise the mechanical properties of nitinol. When welded (for example) to steels, brittle compounds can form which weaken the welds. It is well known that some individuals have nickel sensitivity. In some forms nitinol alloys can have high concentration of nickel on the surface. Also, corrosion of nitinol releases nickel into the body. Further, one is limited to the chemical, corrosive, magnetic, acoustic, mechanical, and other properties of nitinol alloys. [0087] In contrast, amorphous alloys can be produced from a wide range of alloy compositions having more desirable mechanical, fabrication, joining, corrosive, biocompatibility, acoustic, magnetic, or other properties for the application at hand and can be shape set into forms useful as medical devices. These medical devices and methods of forming the medical devices, including methods that are not limited to shape setting, are further described herein.”
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the bone fastener of the combination to be made from an amorphous metal as taught by Richter, comprising a chemical composition comprising a combination of zirconium, copper, nickel, and titanium, and a combination of zirconium, copper, aluminum, and niobium as taught by Kusleika et al. in order to provide the fastener with increased mechanical strength and bone-like elasticity, improved corrosion resistance, and better overall biocompatibility. Furthermore, it would have been obvious to provide the materials in the claimed weight percentages as an obvious matter of design choice, based on the intended application and a patient’s particular needs, and 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) 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Patel (US PG Pub No. 2021/0022873) in view of Martin et al. (US PG Pub No. 2018/0271573) as applied to Claim 1 above and further in view of Kolb (US PG Pub No. 2015/0313658).
Regarding Claim 16 as best understood, the combination of Patel and Martin et al. discloses the cannulated bone fastener as stated above in claim 1, but Patel does not disclose a method of manufacturing the cannulated bone fastener comprising the step of manufacturing the cannulated bone fastener by injection molding or additive manufacturing. Paragraphs [0079-0080] of Patel do disclose that “In an embodiment, the implant may be fabricated from a titanium or tantalum material as described above that is also porous, which is known to enhance bone in-growth, for example with pore sizes ranging in 100 to 900 pm and with a porosity of 60-65% to mimic cancellous bone. Porosity is a measure of the void (i.e. "empty") spaces in a material and is a fraction of the volume of voids expressed as a percentage. Pore sizes of about 600 p have been recommended as optimal for bone ingrowth (N. Taniguchi, et al.,“Effect of pore size on bone ingrowth into porous titanium implants fabricated by additive manufacturing: An in vivo experiment,” Mater Sci Eng C Mater Bioi Appi. 2016 Feb;59:690-701.doi:10.1016/j.msec.2015.10.069. Epub 2015 Oct 28). In an embodiment, the pore sizes may be 300-400 pm. Li, G., Wang, L, Pan, W. et al. In vitro and in vivo study of additive manufactured porous Ti6AI4V scaffolds for repairing bone defects. Sci Rep 6, 34072 (2016).”
Kolb discloses various embodiments of a bone screw (1, Figs. 1-13), wherein “[0061] Fabrication of the various embodiments may benefit from additive manufacturing techniques (i.e. 3D printing). However, the scope of invention is not limited to a specific manufacturing technology. Embodiments may be manufactured from stainless steel, cobalt chromium, titanium, polymers, ceramics and other suitable materials. [0062] In one fabrication method the bone screw 1 is comprised wholly of a material provided by an additive manufacturing process; e.g., printing. In another fabrication method a portion of the bone screw 1 is formed by a first process comprising conventional manufacturing techniques (e.g. machining, casting, rolling, stamping) and a portion of the bone screw 1 is formed by a second process comprising additive manufacturing techniques. By way of example, in one embodiment the central portion 36 is formed using conventional manufacturing techniques and the thread 9 is formed using additive manufacturing techniques.”
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the cannulated bone fastener of the combination to be manufactured by additive manufacturing as taught by Kolb as a well-known and commonly used manufacturing process for surgical devices and implants which provides the added benefit of rapid, cost-effective production and promotes increased osseointegration.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
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