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 .
Claims
Claim Rejections - 35 USC § 102 - Anticipation
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.
1) Claims 1-2 and 6 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Cherian et al. (JMEPEG, 2023).
Cherian et al. disclose temporary metallic orthopedic implants comprising metal alloys. The metal alloy used is a magnesium calcium alloy wherein calcium comprises 0.5% of the alloy. The alloy is coated with a polydioxanone/hydroxyapatite nanocomposition. A temporary metallic orthopedic implant entails attributes like mechanical properties comparable to that of human bone, along with biocompatibility and biodegradability in physiological conditions. Mg-Ca alloys with enhanced corrosion resistance and mechanical properties can be advantageous for biodegradable implants. However, the addition of Ca beyond 1 wt.% decreases the corrosion resistance due to the precipitation of the Mg2Ca intermetallic phase along the grain boundaries. Hence, Mg-Ca alloys with 0.5 wt.% Ca are used as the base material.
Cherian et al. anticipate the instant claims.
2) Claims 1-2, 6-7 and 12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Koo et al. (US 20130131814).
Koo et al. disclose implants comprising biodegradable magnesium alloy (Abstract) having a porous structure. The implant has a high initial strength, and the rigidity (elastic coefficient) of which is similar to that of bone; has an initial bending strength and pullout strength higher than those of bone and which maintains the initial bending strength and pullout strength until an artificial is fixed in bone; the decomposition rate can be controlled such that 60% or more of its initial mechanical properties are retained until the implant has cured after an artificial joint has been fixed on bone using the implant, which is uniformly decomposed from the surface thereof to the inside thereof, and which does not cause a poisonous tissue reaction (for example, inflammation); has no side effects due to itself and the decomposed products thereof; wherein bone cells permeate into the vacant space of the implant when the implant decomposes and is absorbed in bone, so replacing the implant by bone; and can be strongly fixed around bone (paragraph 0009). The biodegradable implant may include a magnesium composite including the biodegradable magnesium alloy and at least one selected from the group consisting of metal, ceramic and polymer (paragraph 0034. The Magnesium alloy comprises mostly magnesium and further comprises calcium. The alloy may further comprise at least an additional metal including zinc and manganese. The magnesium alloy may be represented by formula Mg-Ca-Y where Y is Mn or Zn. The alloy may comprise less than 23% calcium and less than 10% of an additional metal. The porous structure comprises the magnesium alloy coated with ceramic and/or a polymer. Ceramics include calcium phosphate. Polymers may include polydioxanone and poly(glycolide-co-trimethylene carbonate) (also known as polyglyconate). The implants may further comprise actives such as fibronectin.
Koo et al. anticipate the instant claims.
Claim Rejections - 35 USC § 103 - Obviousness
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.
1) Claims 1 -2 and 6-12 are rejected under 35 U.S.C. 103 as being unpatentable over Koo et al. (US 20130131814).
Koo et al. disclose implants comprising biodegradable magnesium alloy (Abstract) having a porous structure. The implant has a high initial strength, and the rigidity (elastic coefficient) of which is similar to that of bone; has an initial bending strength and pullout strength higher than those of bone and which maintains the initial bending strength and pullout strength until an artificial is fixed in bone; the decomposition rate can be controlled such that 60% or more of its initial mechanical properties are retained until the implant has cured after an artificial joint has been fixed on bone using the implant, which is uniformly decomposed from the surface thereof to the inside thereof, and which does not cause a poisonous tissue reaction (for example, inflammation); has no side effects due to itself and the decomposed products thereof; wherein bone cells permeate into the vacant space of the implant when the implant decomposes and is absorbed in bone, so replacing the implant by bone; and can be strongly fixed around bone (paragraph 0009). The biodegradable implant may include a magnesium composite including the biodegradable magnesium alloy and at least one selected from the group consisting of metal, ceramic and polymer (paragraph 0034. The Magnesium alloy comprises mostly magnesium and further comprises calcium. The alloy may further comprise at least an additional metal including zinc and manganese. The magnesium alloy may be represented by formula Mg-Ca-Y where Y is Mn or Zn. The alloy may comprise less than 23% calcium and less than 10% of an additional metal. The porous structure comprises the magnesium alloy coated with ceramic and/or a polymer. Ceramics include calcium phosphate. Polymers may include polydioxanone and poly(glycolide-co-trimethylene carbonate) (also known as polyglyconate). The implants may further comprise actives such as fibronectin. The shape of the implant obtained by forming the molten biodegradable magnesium alloy is not particularly limited as long as it can be used to fix an artificial joint in bone, but may be selected from the group consisting of a screw, a bolt, a pin and a nail (paragraph 0079).
Koo et al. differ from the instant claims insofar as they do not disclose the shape of the implant is a wedge.
However, Koo et al. disclose that shape of the implant obtained by forming the molten biodegradable magnesium alloy is not particularly limited as long as it can be used to fix an artificial joint in bone. The shape of a wedge would determine where it can be implanted into the subject. Therefore, it would have been obvious to have formed the implant into a wedge in order to use it for areas that require a wedge shape.
In regard to the thickness of the coating, the through passage and the cross section, the thickness, through pattern and cross section would affect the contact of the inner structure to the site of implantation and the growth of new tissue at the implantation site. Therefore, it would have taken no more than the relative skill of one of ordinary skill in the art have made the coating a certain thickness, through passage percentage and cross section shape to achieve the desired result.
2) Claims 1-19 are rejected under 35 U.S.C. 103 as being unpatentable over Koo et al. (US 20130131814) in view of Wei (US 20180296343).
Koo et al. disclose implants comprising biodegradable magnesium alloy (Abstract) having a porous structure. The implant has a high initial strength, and the rigidity (elastic coefficient) of which is similar to that of bone; has an initial bending strength and pullout strength higher than those of bone and which maintains the initial bending strength and pullout strength until an artificial is fixed in bone; the decomposition rate can be controlled such that 60% or more of its initial mechanical properties are retained until the implant has cured after an artificial joint has been fixed on bone using the implant, which is uniformly decomposed from the surface thereof to the inside thereof, and which does not cause a poisonous tissue reaction (for example, inflammation); has no side effects due to itself and the decomposed products thereof; wherein bone cells permeate into the vacant space of the implant when the implant decomposes and is absorbed in bone, so replacing the implant by bone; and can be strongly fixed around bone (paragraph 0009). The biodegradable implant may include a magnesium composite including the biodegradable magnesium alloy and at least one selected from the group consisting of metal, ceramic and polymer (paragraph 0034. The Magnesium alloy comprises mostly magnesium and further comprises calcium. The alloy may further comprise at least an additional metal including zinc and manganese. The magnesium alloy may be represented by formula Mg-Ca-Y where Y is Mn or Zn. The alloy may comprise less than 23% calcium and less than 10% of an additional metal. The porous structure comprises the magnesium alloy coated with ceramic and/or a polymer. Ceramics include calcium phosphate. Polymers may include polydioxanone and poly(glycolide-co-trimethylene carbonate) (also known as polyglyconate). The implants may further comprise actives such as fibronectin. The shape of the implant obtained by forming the molten biodegradable magnesium alloy is not particularly limited as long as it can be used to fix an artificial joint in bone, but may be selected from the group consisting of a screw, a bolt, a pin and a nail (paragraph 0079).
Koo et al. differ from the instant claims insofar as it does not disclose the type of ceramics.
Wei disclose suitable ceramics for porous implants include dicalcium phosphate and octacalcium phosphate. These components are ceramic and/or bone substitute materials.
It would have been obvious to one of ordinary skill in the art prior to filing the instant application to have added dicalcium phosphate and octacalcium phosphate as the ceramic materials in the implants of Koo et al. because they are suitable ceramic and bone substitute materials used in implants.
Koo et al. in view of Wei differs from the instant claims insofar as it does not disclose vitamin D.
Binette et al. disclose implant. Vitamin D is used to fix the implants to bony sites because they will act to induce calcium deposition at the point of insertion or attachment onto bone. The implant can be affixed to a desired position relative to the tissue injury, such as within a tear or lesion. Once the implant is placed in the desired position or lesion, it can be affixed by using a suitable technique. In one aspect, the implant can be affixed by a chemical and/or mechanical fastening technique. Suitable chemical fasteners include glues and/or adhesive such as fibrin glue (paragraph 0090).
It would have been obvious to one of ordinary skill in the art prior to filing the instant application to have added vitamin D to the implants of Koo et al. in view of Wei motivated by the desire to assist in fixing the implant to bony sites, and to have added fibrin to the implants to affix the implant in the desired position.
In regards to the amount of vitamin D, vitamin D contributes to fixing implants to bony sites making it a result effective variable. It would have taken no more than the relative skill of one of ordinary skill in the art to have used 0.1 top 4% vitamin D in the implants of Koo et al. motivated by the desired adhesive effect.
In regards to the manganese and zinc, Generally, it is prima facie obvious to combine two compositions, each of which is taught by the prior art to be useful for same purpose, in order to form a third composition to be used for the very same purpose. The idea for combining them flows logically from their having been individually taught in the prior art. See MPEP 2144.06. Koo et al. suggests using zinc and manganese in mixtures in the magnesium alloy. Therefore it would have been obvious to one of ordinary skill in the art to have used a mixture of zinc and manganese in the implants of Koo et al. because it is suggested and use for the same purpose.
Koo et al. disclose that shape of the implant obtained by forming the molten biodegradable magnesium alloy is not particularly limited as long as it can be used to fix an artificial joint in bone. The shape of a wedge would determine where it can be implanted into the subject. Therefore, it would have been obvious to have formed the implant into a wedge in order to use it for areas that require a wedge shape.
In regard to the thickness of the coating, the through passage and the cross section, the thickness, through pattern and cross section would affect the contact of the inner structure to the site of implantation and the growth of new tissue at the implantation site. Therefore, it would have taken no more than the relative skill of one of ordinary skill in the art have made the coating a certain thickness, through passage percentage and cross section shape to achieve the desired result.
Claims 1-19 are rejected.
No claims allowed.
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/LEZAH ROBERTS/ Primary Examiner, Art Unit 1612