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 .
Election/Restrictions
The application is directed to multiple invention and/or species. The examiner reserves the right to restrict the inventions and/or species if any amendments to claims cause the scope of the inventions and/or the species to divert to the extend of creating a serious search burden for the examiner.
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 1-3, 7-15, and 19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Trieu (U.S. Publication 2015/0196339).
Regarding claims 1-3 and 7-9:
Trieu discloses a device, such as a bone screw (claim 7; for example see Figure 1), comprising:
(claim 1) a metallic shaft (32; paragraphs 15 and 30-31)
(claim 7) wherein the metallic shaft includes
(claim 7) a head (42) at a proximal end of the metallic shaft
(claim 1) an outer layer (50; paragraph 35) disposed on an outer surface of the shaft
(claim 1) the outer layer being capable of limiting the effect of an electromagnetic field on the metallic shaft (the outer layer is disclosed as being made from a polymer as discussed in paragraphs 18, 30, and 36 that insulates and is capable of limiting the effect of an electromagnetic field on the metallic shaft)
(claim 2) wherein the outer layer is a ceramic material or is a PEEK material (paragraphs 16, 19, 30, 36, 38, and 46; the disclosure states that the polymer coating can be made from material such as polyether and continues to disclose that the polymer may contain HA particles, i.e. a known biocompatible ceramic, and that the portions of the device can be made from PEEK, therefore one of ordinary skill in the art would understand that a polymer with ceramic material and/or PEEK, which is a known homopolymer used in the art (paragraph 46), can be used for the polymer coating)
(claim 3) wherein the outer layer is a coating having a minimum thickness in a range of about 0.006 inches to about 0.030 inches (paragraphs 40 and 45; 1mm is approximately 0.039 inches and paragraph 45 discloses the coating being between 1nm and 1mm, i.e. less than 0.039 inches)
(claim 9) wherein the outer layer is further capable of preventing radiofrequency exposure to the fastener from heating the metallic shaft (the outer layer is disclosed as being made from a polymer as discussed in paragraphs 18, 30, and 36 that insulates and is capable of preventing radiofrequency exposure to the fastener from heating the metallic shaft)
(claim 1) wherein the outer layer includes a threaded portion along its length
(claim 8) wherein the threaded portion extends to a distal tip (54) of the device
Regarding claims 10-15 and 19:
Trieu discloses a device, such as a bone screw, (claim 12; for example see Figure 1) comprising:
(claim 10) a metallic shaft (32; paragraphs 15 and 30-31) including
(claims 11 and 12) a proximal end comprising a head (42)
(claims 11 and 13) a distal end including a distal tip (54)
(claim 10) an outer layer (50; paragraph 35) disposed on an outer surface of the shaft
(claim 10) wherein the outer layer is further capable of preventing radiofrequency exposure to the fastener from heating the metallic shaft (the outer layer is disclosed as being made from a polymer as discussed in paragraphs 18, 30, and 36 that insulates and is capable of preventing radiofrequency exposure to the fastener from heating the metallic shaft)
(claim 10) wherein the outer layer encloses a majority of the metallic shaft
(claim 11) wherein a portion of the metallic shaft between the proximal end and the distal end are enclosed by the outer layer
(claim 14) wherein the outer layer is a ceramic material or is a PEEK material (paragraphs 16, 19, 30, 36, 38, and 46; the disclosure states that the polymer coating can be made from material such as polyether and continues to disclose that the polymer may contain HA particles, i.e. a known biocompatible ceramic, and that the portions of the device can be made from PEEK, therefore one of ordinary skill in the art would understand that a polymer with ceramic material and/or PEEK, which is a known homopolymer used in the art (paragraph 46), can be used for the polymer coating)
(claim 15) wherein the outer layer is a coating having a minimum thickness in a range of about 0.006 inches to about 0.030 inches (paragraphs 40 and 45; 1mm is approximately 0.039 inches and paragraph 45 discloses the coating being between 1nm and 1mm, i.e. less than 0.039 inches)
(claim 19) the outer layer being capable of limiting the effect of an electromagnetic field on the metallic shaft (the outer layer is disclosed as being made from a polymer as discussed in paragraphs 18, 30, and 36 that insulates and is capable of limiting the effect of an electromagnetic field on the metallic shaft)
Claims 1, 2, 4-14, and 16-19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Biedermann (U.S. Publication 2014/0005731).
Regarding claims 1, 2, and 4-9:
Biedermann discloses a device, such as a bone screw, (for example see Figures 19-29) comprising:
(claim 1) a metallic shaft (2; paragraph 54) including
(claim 7) a head (3) at a proximal end
(claim 1) an outer layer (1; paragraph 50) disposed on an outer surface of the shaft
(claim 1) the outer layer being capable of limiting the effect of an electromagnetic field on the metallic shaft (element 1 is disclosed as being made from PEEK, which is the same material disclosed in the application and is therefore capable of performing the function)
(claim 1) wherein the outer layer includes a threaded portion along its length
(claim 8) wherein the threaded portion extends to a distal tip (24) of the device
(claim 2) wherein the outer layer is a PEEK material (paragraph 50)
(claim 4) wherein the outer layer is a cannulated sleeve that is removably attachable to the metallic shaft such that the cannulated sleeve encloses at least a majority of the metallic shaft
(claim 5) wherein the cannulated sleeve is open at a first end of the sleeve and at a second end of the sleeve opposite the first end such that a tip of the metallic shaft is exposed through one of the ends
(claim 6) wherein the metallic shaft and the cannulated sleeve both include a plurality of flat surfaces (the surfaces that extend between 26’ and 26a’ on the shaft and the matching corresponding surfaces of element 18 in the sleeve) meeting at sharp edges (sharp relative to the rounded surface 26’) such that when the cannulated sleeve is disposed over the metallic shaft the cannulated sleeve is prevented from rotating relative to the metallic shaft
(claim 9) wherein the outer layer is capable of preventing radiofrequency exposure to the fastener from heating the metallic shaft (element 1 is disclosed as being made from PEEK, which is the same material disclosed in the application and is therefore capable of performing the function)
Regarding claims 10-14 and 16-19:
Biedermann discloses a device, such as a bone screw, (for example see Figures 19-29) comprising:
(claim 10) a metallic shaft (2) including
(claims 11 and 12) a proximal end including a head (3)
(claims 11 and 13) a distal end including a tip (24)
(claim 10) an outer layer disposed on a surface of the metallic shaft
(claim 10) wherein the outer layer is capable of preventing radiofrequency exposure to the fastener from heating the metallic shaft (element 1 is disclosed as being made from PEEK, which is the same material disclosed in the application and is therefore capable of performing the function)
(claim 10) wherein the outer layer encloses a majority of the metallic shaft
(claim 11) wherein the outer layer encloses the portion of the metallic shaft between the proximal end and the distal end
(claim 14) wherein the outer layer is made from PEEK (paragraph 50)
(claim 16) wherein the outer layer is a cannulated sleeve that is removably attachable to the metallic shaft
(claim 17) wherein the cannulated sleeve is open at a first end and at a second end opposite the first end such that the tip of the shaft is exposed through one of the ends of the sleeve
(claim 18) wherein the metallic shaft and the cannulated sleeve both include a plurality of flat surfaces (the surfaces that extend between 26’ and 26a’ on the shaft and the matching corresponding surfaces of element 18 in the sleeve) meeting at sharp edges (sharp relative to the rounded surface 26’) such that when the cannulated sleeve is disposed over the metallic shaft the cannulated sleeve is prevented from rotating relative to the metallic shaft
(claim 19) wherein the outer layer being capable of limiting the effect of an electromagnetic field on the metallic shaft (element 1 is disclosed as being made from PEEK, which is the same material disclosed in the application and is therefore capable of performing the function)
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 20 is rejected under 35 U.S.C. 103 as being unpatentable over Biedermann (U.S. Publication 2014/0005731) in view of McDonnell (U.S. Publication 2016/0038206).
Biedermann discloses a method comprising:
(claim 20) anchoring a bone screw in a bone of a patient (for example see Figures 1A and 1B)
(claim 20) the bone screw including a metallic shaft (2) and a PEEK outer layer (1) enclosing an outer surface of the metallic shaft
Biedermann fails to disclose the method further comprising the step of conducting an MRI, wherein the outer layer reduces the temperature change of the metallic shaft during the MRI. McDonnell teaches a method comprising the step of anchoring a bone screw (102) with a polymer outer layer (100; paragraph 142) into a bone of a patient (for example see Figures 1A-1B), wherein the method further includes the step of performing an MRI on a patient (paragraph 150) such that the outer layer insulates the bone screw during the MRI to reduce the temperature change in the bone screw in order to prevent any pain and/or damage to the patient near the bone screw and outer layer during the MRI (paragraph 150). It would have been obvious to one having ordinary skill in the art at the time the invention was filed to perform the method of Biedermann further comprising the step of performing an MRI on the patient and wherein the outer layer of the device insulates the metallic shaft of the device during the MRI to reduce any temperature changes of the metallic shaft in view of McDonell in order to prevent any pain and/or damage to the patient near the bone screw and outer layer during the MRI.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See PTO-892 for cited references the examiner felt were relevant to the application.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Nicholas Woodall whose telephone number is (571) 272-5204. The examiner can normally be reached on Monday-Friday 8am to 5:30pm.
If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, Kevin Truong, at (571. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/NICHOLAS W WOODALL/Primary Examiner, Art Unit 3775