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 .
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.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 61-74 and 89-102 are rejected under 35 U.S.C. 102(a)(1) as being clearly anticipated by WO 2014176025 A1 (hereafter --Patel--).
Regarding Claim 61, Patel discloses a method for forming a spinal rod that includes a metal coated rod comprising the steps of:
a) providing a rod core (see paragraph [0010]); said rod core is formed of a metal alloy that includes at least about 60 wt.% of a solid solution of rhenium and molybdenum alloy (see paragraph [0010] denoting that the core of the rod is formed of a metal or novel alloy, an option being a MoRe alloy, see paragraphs [0014] and [0016]); said metal alloy includes at least about 20 wt.% rhenium and/or at least about 20 wt.% molybdenum (see paragraphs [0014] and [0016]);
b) providing coating material; said coating material is formed of a different material from said metal alloy used to form said rod core (see paragraph [0011]); said coating material is selected from form the group consisting of iron, cobalt-chromium, titanium alloy, stainless steel, rhenium alloy, molybdenum alloy, polymer material, and ceramic material (see paragraphs [0010] denoting the novel alloy can be used to form a coating on a portion of all of a medical device, see paragraph [0007] denoting the novel alloy can be made of metals that are used to form the novel alloy are non-limiting. Generally, such metals include, nickel and chromium and one or more alloying agents such as, but are not limited to, aluminum, calcium, carbon, cerium oxide, cobalt, copper, gold, hafnium, iron, lanthanum oxide, lead, magnesium, molybdenum, niobium, osmium, platinum, rare earth metals, rhenium, silver, tantalum, technetium, titanium, tungsten, vanadium, yttrium, yttrium oxide, zinc, zirconium, zirconium oxide, and/or alloys of one or more of such components (e.g., MoHfC, MoY.sub.20.sub.3, MoCs.sub.20, MoW, MoTa, MoZr0.sub.2, MoLa.sub.20.sub.3, MoRe alloy, etc., see also paragraphs [0011] and [0048]); said coating material has a different composition from said core material (see paragraph [0011]); and
c) coating said coating material on at least a portion of an outer surface of said rod core to formed said metal coated rod (see paragraph [0011]); said rod core constitutes at least 50% of an overall cross- section of said metal coated rod (see paragraph [0011] denoting the core and the other layer of the rod can each form 50-99% of the overall cross section of the rod).
Regarding Claim 62, Patel discloses the method as defined in claim 61, wherein said metal alloy includes 40-60 wt.% rhenium and 40-60 wt.% molybdenum (see paragraphs [0014] and [0016]).
Regarding Claim 63, Patel discloses the method as defined in claim 61, wherein said content of said rhenium and molybdenum in said metal alloy constitutes at least 95 wt.% of said metal alloy (see paragraph [0014] denoting the content of molybdenum and rhenium in the novel alloy is at least about 99.5 weight percent); said metal alloy includes one or more metals selected from the group consisting of copper, manganese, silicon, and titanium (see paragraph [0013]).
Regarding Claim 64, Patel discloses the method as defined in claim 62, wherein said content of said rhenium and molybdenum in said metal alloy constitutes at least 95 wt.% of said metal alloy (see paragraph [0014] denoting the content of molybdenum and rhenium in the novel alloy is at least about 99.5 weight percent); said metal alloy includes one or more metals selected from the group consisting of copper, manganese, silicon, and titanium (see paragraphs [0013] and [0017]).
Regarding Claim 65, Patel discloses the method as defined in claim 61, wherein said coating material is selected from the group consisting of titanium, titanium alloy, cobalt-chromium alloy, and stainless steel (see paragraphs [0010] denoting the novel alloy can be used to form a coating on a portion of all of a medical device, see paragraph [0007] denoting the novel alloy can be made of metals that are used to form the novel alloy are non-limiting. Generally, such metals include, nickel and chromium and one or more alloying agents such as, but are not limited to, aluminum, calcium, carbon, cerium oxide, cobalt, copper, gold, hafnium, iron, lanthanum oxide, lead, magnesium, molybdenum, niobium, osmium, platinum, rare earth metals, rhenium, silver, tantalum, technetium, titanium, tungsten, vanadium, yttrium, yttrium oxide, zinc, zirconium, zirconium oxide, and/or alloys of one or more of such components (e.g., MoHfC, MoY.sub.20.sub.3, MoCs.sub.20, MoW, MoTa, MoZr0.sub.2, MoLa.sub.20.sub.3, MoRe alloy, etc.).
Regarding Claim 66, Patel discloses the method as defined in claim 64, wherein said coating material is selected from the group consisting of titanium, titanium alloy, cobalt-chromium alloy, and stainless steel (see paragraphs [0010] denoting the novel alloy can be used to form a coating on a portion of all of a medical device, see paragraph [0007] denoting the novel alloy can be made of metals that are used to form the novel alloy are non-limiting. Generally, such metals include, nickel and chromium and one or more alloying agents such as, but are not limited to, aluminum, calcium, carbon, cerium oxide, cobalt, copper, gold, hafnium, iron, lanthanum oxide, lead, magnesium, molybdenum, niobium, osmium, platinum, rare earth metals, rhenium, silver, tantalum, technetium, titanium, tungsten, vanadium, yttrium, yttrium oxide, zinc, zirconium, zirconium oxide, and/or alloys of one or more of such components (e.g., MoHfC, MoY.sub.20.sub.3, MoCs.sub.20, MoW, MoTa, MoZr0.sub.2, MoLa.sub.20.sub.3, MoRe alloy, etc.).
Regarding Claim 67, Patel discloses the method as defined in claim 61, wherein said rod core constitutes at least 90% of an overall cross-section of said metal coated rod (see paragraph [0011] denoting the core and the other layer of the rod can each form 50-99% of the overall cross section of the rod).
Regarding Claim 68, Patel discloses the method as defined in claim 66, wherein said rod core constitutes at least 90% of an overall cross-section of said metal coated rod (see paragraph [0011] denoting the core and the other layer of the rod can each form 50-99% of the overall cross section of the rod).
Regarding Claim 69, Patel discloses the method as defined in claim 61, further including the steps of: drawing down said outer cross-sectional area of said metal coated rod by a reducing mechanism (see paragraph [0062]); annealing said metal coated rod at an annealing temperature in an oxygen reducing environment or inert environment after said rod or tube has been drawn down (see paragraphs [0063], [0064], and [0065]); and, cooling said annealed metal coated rod (see paragraph [0064]).
Regarding Claim 70, Patel discloses the method as defined in claim 68, further including the steps of: drawing down said outer cross-sectional area of said metal coated rod by a reducing mechanism (see paragraph [0062]); annealing said metal coated rod at an annealing temperature in an oxygen reducing environment or inert environment after said rod or tube has been drawn down (see paragraphs [0063], [0064], and [0065]); and, cooling said annealed metal coated rod (see paragraph [0064]).
Regarding Claim 71, Patel discloses the method as defined in claim 61, wherein at least one region of an outer surface of said metal coated rod includes at least one biological agent (see paragraph [0045]).
Regarding Claim 72, Patel discloses the method as defined in claim 68, wherein at least one region of an outer surface of said metal coated rod includes at least one biological agent (see paragraph [0045]).
Regarding Claim 73, Patel discloses the method as defined in claim 61, wherein at least one region of said metal coated rod includes at least one polymer; at least one said polymer at least partially coats, encapsulates, or combinations thereof, at least one biological agent (see paragraph [0054] denoting that the adhesive can include and/or be mixed with one or more polymers; however, this is not required. The one or more polymers can be used to 1) control the time of adhesion provided by said adhesive, 2) control the rate of degradation of the adhesive, and/or 3) control the rate of release of one or more biological agents from the adhesive and/or diffusing or penetrating through the adhesive layer).
Regarding Claim 74, Patel discloses the method as defined in claim 68, wherein at least one region of said metal coated rod includes at least one polymer; at least one said polymer at least partially coats, encapsulates, or combinations thereof, at least one biological agent (see paragraph [0054] denoting that the adhesive can include and/or be mixed with one or more polymers; however, this is not required. The one or more polymers can be used to 1) control the time of adhesion provided by said adhesive, 2) control the rate of degradation of the adhesive, and/or 3) control the rate of release of one or more biological agents from the adhesive and/or diffusing or penetrating through the adhesive layer).
Regarding Claim 89, Patel discloses a method for forming a spinal rod that includes a metal coated rod comprising the steps of: a) providing a rod core (see paragraph [0010]); said rod core is formed of a metal alloy that includes at least about 60 wt.% of a solid solution of rhenium and one or more metals selected form the group consisting of molybdenum, calcium, chromium, cobalt, copper, gold, hafnium, iron, lead, magnesium, nickel, niobium, osmium, platinum, rare earth metals, rhenium, silver, tantalum, technetium, titanium, tungsten, vanadium, yttrium, zinc, and zirconium (see paragraph [0010] denoting that the core of the rod is formed of a metal or novel alloy, an option being a MoRe alloy, see paragraphs [0014] and [0016]); said metal alloy includes at least about 20 wt.% rhenium (see paragraphs [0014] and [0016]); b) providing coating material; said coating material is formed of a different material from said metal alloy used to form said rod core (see paragraph [0011]); said coating material is selected from form the group consisting of iron, cobalt-chromium, titanium alloy, stainless steel, rhenium alloy, molybdenum alloy, polymer material, and ceramic material; said coating material has a different composition from said core material (see paragraph [0007] denoting the novel alloy can be made of metals that are used to form the novel alloy are non-limiting. Generally, such metals include, nickel and chromium and one or more alloying agents such as, but are not limited to, aluminum, calcium, carbon, cerium oxide, cobalt, copper, gold, hafnium, iron, lanthanum oxide, lead, magnesium, molybdenum, niobium, osmium, platinum, rare earth metals, rhenium, silver, tantalum, technetium, titanium, tungsten, vanadium, yttrium, yttrium oxide, zinc, zirconium, zirconium oxide, and/or alloys of one or more of such components (e.g., MoHfC, MoY.sub.20.sub.3, MoCs.sub.20, MoW, MoTa, MoZr0.sub.2, MoLa.sub.20.sub.3, MoRe alloy, etc., see also paragraphs [0011] and [0048]); and c) coating said coating material on at least a portion of an outer surface of said rod core to formed said metal coated rod (see paragraph [0011]); said rod core constitutes at least 50% of an overall cross- section of said metal coated rod (see paragraph [0011] denoting the core and the other layer of the rod can each form 50-99% of the overall cross section of the rod).
Regarding Claim 90, Patel discloses the method as defined in claim 89, wherein said metal alloy includes 40-60 wt.% rhenium and 40-60 wt.% molybdenum (see paragraphs [0014] and [0016]).
Regarding Claim 91, Patel discloses the method as defined in claim 89, wherein said total content of said rhenium and molybdenum in said metal alloy constitutes at least 95 wt.% of said metal alloy (see paragraph [0014] denoting the content of molybdenum and rhenium in the novel alloy is at least about 99.5 weight percent); said metal alloy includes one or more metals selected from the group consisting of copper, manganese, silicon, and titanium (see paragraph [0013]).
Regarding Claim 92, Patel discloses the method as defined in claim 89, wherein said coating material is selected from the group consisting of titanium, titanium alloy, cobalt-chromium alloy, and stainless steel (see paragraphs [0010] denoting the novel alloy can be used to form a coating on a portion of all of a medical device, see paragraph [0007] denoting the novel alloy can be made of metals that are used to form the novel alloy are non-limiting. Generally, such metals include, nickel and chromium and one or more alloying agents such as, but are not limited to, aluminum, calcium, carbon, cerium oxide, cobalt, copper, gold, hafnium, iron, lanthanum oxide, lead, magnesium, molybdenum, niobium, osmium, platinum, rare earth metals, rhenium, silver, tantalum, technetium, titanium, tungsten, vanadium, yttrium, yttrium oxide, zinc, zirconium, zirconium oxide, and/or alloys of one or more of such components (e.g., MoHfC, MoY.sub.20.sub.3, MoCs.sub.20, MoW, MoTa, MoZr0.sub.2, MoLa.sub.20.sub.3, MoRe alloy, etc.).
Regarding Claim 93, Patel discloses the method as defined in claim 91, wherein said coating material is selected from the group consisting of titanium, titanium alloy, cobalt-chromium alloy, and stainless steel (see paragraphs [0010] denoting the novel alloy can be used to form a coating on a portion of all of a medical device, see paragraph [0007] denoting the novel alloy can be made of metals that are used to form the novel alloy are non-limiting. Generally, such metals include, nickel and chromium and one or more alloying agents such as, but are not limited to, aluminum, calcium, carbon, cerium oxide, cobalt, copper, gold, hafnium, iron, lanthanum oxide, lead, magnesium, molybdenum, niobium, osmium, platinum, rare earth metals, rhenium, silver, tantalum, technetium, titanium, tungsten, vanadium, yttrium, yttrium oxide, zinc, zirconium, zirconium oxide, and/or alloys of one or more of such components (e.g., MoHfC, MoY.sub.20.sub.3, MoCs.sub.20, MoW, MoTa, MoZr0.sub.2, MoLa.sub.20.sub.3, MoRe alloy, etc.).
Regarding Claim 94, Patel discloses the method as defined in claim 89, wherein said rod core constitutes at least 90% of an overall cross-section of said metal coated rod (see paragraph [0011] denoting the core and the other layer of the rod can each form 50-99% of the overall cross section of the rod).
Regarding Claim 95, Patel discloses the method as defined in claim 93, wherein said rod core constitutes at least 90% of an overall cross-section of said metal coated rod (see paragraph [0011] denoting the core and the other layer of the rod can each form 50-99% of the overall cross section of the rod).
Regarding Claim 96, Patel discloses the method as defined in claim 89, wherein said coating material includes titanium (see paragraphs [0010] denoting the novel alloy can be used to form a coating on a portion of all of a medical device, see paragraph [0007] denoting the novel alloy can be made of metals that are used to form the novel alloy are non-limiting. Generally, such metals include, nickel and chromium and one or more alloying agents such as, but are not limited to, aluminum, calcium, carbon, cerium oxide, cobalt, copper, gold, hafnium, iron, lanthanum oxide, lead, magnesium, molybdenum, niobium, osmium, platinum, rare earth metals, rhenium, silver, tantalum, technetium, titanium, tungsten, vanadium, yttrium, yttrium oxide, zinc, zirconium, zirconium oxide, and/or alloys of one or more of such components (e.g., MoHfC, MoY.sub.20.sub.3, MoCs.sub.20, MoW, MoTa, MoZr0.sub.2, MoLa.sub.20.sub.3, MoRe alloy, etc.).
Regarding Claim 97, Patel discloses the method as defined in claim 95, wherein said coating material includes titanium (see paragraphs [0010] denoting the novel alloy can be used to form a coating on a portion of all of a medical device, see paragraph [0007] denoting the novel alloy can be made of metals that are used to form the novel alloy are non-limiting. Generally, such metals include, nickel and chromium and one or more alloying agents such as, but are not limited to, aluminum, calcium, carbon, cerium oxide, cobalt, copper, gold, hafnium, iron, lanthanum oxide, lead, magnesium, molybdenum, niobium, osmium, platinum, rare earth metals, rhenium, silver, tantalum, technetium, titanium, tungsten, vanadium, yttrium, yttrium oxide, zinc, zirconium, zirconium oxide, and/or alloys of one or more of such components (e.g., MoHfC, MoY.sub.20.sub.3, MoCs.sub.20, MoW, MoTa, MoZr0.sub.2, MoLa.sub.20.sub.3, MoRe alloy, etc.).
Regarding Claim 98, Patel discloses the method as defined in claim 89, wherein a hardness of said core material has a greater hardness than a hardness of said metal coating; said coating material has a hardness of 250 Vickers to 550 Vickers; said core material has a hardness of 350 Vickers to 1000 Vickers (see paragraph [0010] denoting the inner hardness can range from 250 Vickers to 550 Vickers, the outer harness can vary from 350 Vickers to 1000 Vickers when using novel alloy (e.g., MoHfC, MoY.sub.20.sub.3, MoCs.sub.20, MoW, MoTa, MoZr0.sub.2, MoRe alloy, NiCoCrMo alloy, NiCrMoTi alloy, NiCrCuNb alloy, TiAlV alloy, etc.).
Regarding Claim 99, Patel discloses the method as defined in claim 97, wherein a hardness of said core material has a greater hardness than a hardness of said metal coating; said coating material has a hardness of 250 Vickers to 550 Vickers; said core material has a hardness of 350 Vickers to 1000 Vickers (see paragraph [0010] denoting the inner hardness can range from 250 Vickers to 550 Vickers, the outer harness can vary from 350 Vickers to 1000 Vickers when using novel alloy (e.g., MoHfC, MoY.sub.20.sub.3, MoCs.sub.20, MoW, MoTa, MoZr0.sub.2, MoRe alloy, NiCoCrMo alloy, NiCrMoTi alloy, NiCrCuNb alloy, TiAlV alloy, etc.).
Regarding Claim 100, Patel discloses the method as defined in claim 89, wherein said metal alloy of said metal coating includes at least 95 wt.% of a solid solution of a rhenium and molybdenum and chromium (see paragraph [0008] denoting the medical device includes at least about 95 weight percent of the novel metal alloy, see paragraph [0013] denoting that the novel alloy can include chromium and an alloying agent, an option being MoRe (molybdenum rhenium)).
Regarding Claim 101, Patel discloses the method as defined in claim 89, further including the step of forming a nitride outer coating on an outer surface of said coating material by one or more processes selected from the group consisting of a gas nitriding process, a salt-bath nitriding process, or a plasma nitriding process (see paragraph [0063]).
Regarding Claim 102, Patel discloses the method as defined in claim 89, wherein said core material is at least partially formed from powdered particles (see paragraph [0059]) having an average particle size of less than 74 microns that have been sintered together (see paragraph [0059] denoting the average particle size of the metal powders is less than about 200 mesh (e.g., less than 74 microns)).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US 20100057197 A1: This reference discloses an implant with molybdenum and rhenium with a coating provided over it, an implant option being a spinal rod.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PARIS MARIE BLASS whose telephone number is (703)756-5375. The examiner can normally be reached Monday - Thursday 9 a.m. - 7 p.m. ET.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melanie Tyson can be reached at 571-272-9062. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/PARIS MARIE BLASS/Examiner, Art Unit 3774
/SARAH W ALEMAN/Primary Examiner, Art Unit 3774
Prosecution Insights