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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 3/15/2025 and 12/6/2024 is being considered by the examiner.
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 4 and 5 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 4 recites the limitation "the mechanical coupling" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 5 recites the limitation "the mechanical coupling" in line 1. There is insufficient antecedent basis for this limitation in the claim.
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.
Claim(s) 1-7 and 9-13 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 2005/0004417 (Nelson et al., hereinafter Nelson).
As to claim 1, Nelson discloses a device comprising:
a first magnetic member (see first magnetic member 12, Fig 1; 12 comprises a permanent magnet, para [0066]) configured to be mechanically coupled to a first bone in a patient (12 can be fixated to a bone, para [0135]). the first bone having a first growth plate (a bone will inherently have a growth plate, para [0135]); and
a second magnetic member (see second magnetic member 14, Fig 1; 14 comprises a permanent magnet, para [0066]) configured to be implanted in the patient (14 can be implanted, para [0133]), wherein placement of the first and second magnetic members is chosen to modulate bone growth by exerting at least one of a compressive force and a tensile force across the first growth plate when mechanically coupled to the first bone and implanted in the patient respectively (magnetic members 12 and 14 possess magnetic poles and thus can be positioned to exert a force across a growth plate depending on their positioning, para [0070]).
As to claim 2, Nelson discloses the device of claim 1, wherein:
the second magnetic member is configured to be mechanically coupled to a second bone in the patient (magnetic member 14 can be fixated to a bone so can be coupled to a different bone than member 12, para [0135]), the second bone having a second growth plate (a bone will inherently have a growth plate, para [0135]); and
placement of the first and second magnetic members is chosen to modulate bone growth by exerting at least one of a compressive force and a tensile force across the second growth plate when mechanically coupled to the first bone and the second bone respectively (magnetic members 12 and 14 possess magnetic poles and thus can be positioned to exert a force across a growth plate depending on their positioning, para [0070]).
As to claim 3, Nelson discloses the device of claim 1, wherein the second magnetic member is configured to be mechanically coupled to the first bone (magnetic member 14 can be fixated to a bone so can be coupled to the same bone as member 12, para [0135]).
As to claim 4, Nelson discloses the device of claim 1, wherein configured to be mechanically coupled (see box VIII) comprises being at least partially embedded within the first bone (magnetic member 12 can include a screw and the device is a size that can be embedded in tissue, para [0133]; the tissue is a bone, para [0135]).
As to claim 5, Nelson discloses the device of claim 1, wherein configured to be mechanically coupled (see box VIII) comprises being mechanically attached to, but located outside of the first bone (magnetic member 12 can include a screw so the screw can be embedded so the magnet is located outside of the bone, para [0133]; the tissue is a bone, para [0135]; can be attached with adhesive, sutures, clips para [0133]).
As to claim 6, Nelson discloses the device of claim 4, wherein the device further comprises a non-magnetic enclosure (magnetic member 12 is encapsulated within a protective material 68 such as titanium which is non-magnetic, para [0075]) that encases the first magnetic member (the protective material encapsulates the magnetic member 12, para [0075]).
As to claim 7, Nelson discloses the device of claim 6, wherein the non-magnetic enclosure is made of titanium (protective material 68 is made of titanium, para [0075]).
As to claim 9, Nelson discloses a device comprising:
a first magnetic member (see first magnetic member 12, Fig 1; 12 comprises a permanent magnet, para [0066]) configured to be embedded within an anterior portion of a first vertebral body of a patient (see how 12 is capable of being embedded in the vertebra due to its small size, Fig 1; 12 is a flexible strip measuring 4 mm X 10 mm X 40 mm, para [0088], the size of 12 is inherently smaller than a vertebra as evidenced by the article entitled "Geometrical dimensions of the lower lumber vertebra - analysis of data from digitized CT images" by Zhou et al (hereinafter 'Zhou'), Table 1), the anterior portion of the first vertebral body having a top and bottom growth plate (a first vertebral body inherently will have a top and bottom growth plate, para [0135]); and
a second magnetic member (see second magnetic member 14, Fig 1; 14 comprises a permanent magnet, para [0066]) configured to be embedded within an anterior portion of a second vertebral body of the patient (magnetic member 14 is the same size as 12 so can be embedded in a vertebra, para [0088], as evidenced by Zhou, Table 1), the anterior portion of the second vertebral body having a top and bottom growth plate (a second vertebral body will inherently have a top and bottom growth plate, para [0135]), wherein placement of the first and second magnetic members is chosen to modulate bone growth by exerting a compressive force across the bottom growth plate of the first vertebral body and the top growth plate of the second vertebral body when embedded within the anterior portions of the first and second vertebral bodies respectively (magnetic members 12 and 14 possess magnetic poles and thus can be positioned to exert a compressive force across the growth plates depending on their positioning, para [0070]).
As to claim 10, Nelson discloses the device of claim 9, wherein the first and second vertebral bodies are adjacent to each other on a spine of the patient (the devices 12 and 14 can be implanted anywhere such as adjacent vertebral bodies, para [0131]).
As to claim 11, Nelson teaches the device of claim 10, further comprising a third magnetic member (there can be an additional magnetic member 12 or 14, para [0066], for example see two magnetic members 12 and a third magnetic member 14, Fig 2) configured to be embedded within an anterior portion of a third vertebral body of the patient (a flexible strip measuring 4 mm X 10 mm X 40 mm, para [0088], the size is smaller than a vertebra as evidenced by Zhou, Table 1), the anterior portion of the third vertebral body having a top and bottom growth plate (a third vertebral body will inherently have a top and bottom growth plate, para [0135]), wherein:
the second and third vertebral bodies are adjacent to each other on the spine of the patient (the devices can be implanted anywhere such as adjacent vertebral bodies, para [0131]); and
placement of the second and third magnetic members is chosen to modulate bone growth by exerting a compressive force across the bottom growth plate of the second vertebral body and the top growth plate of third vertebral body when embedded within the anterior portions of the second and third vertebral bodies respectively (forces can be attracting or repulsive depending on the orientation and thus the members can be positioned to exert a compressive force across the growth plates depending on their positioning, para [0070]).
As to claim 12, Nelson teaches the device of claim 11, wherein the compressive force exerted by the first and second magnetic members on the bottom growth plate of the first vertebral body and the top growth plate of the second vertebral body is greater in magnitude than the compressive force exerted by the second and third magnetic members on the bottom growth plate of the second vertebral body and the top growth plate of the third vertebral body (the magnetic forces can be altered depending on the orientation of poles and thus the members can be positioned to exert desired compressive forces across the growth plates depending on their orientation, para [0070]).
As to claim 13, Nelson discloses the device of claim 9, wherein:
the first magnetic member is encased in a first non-magnetic enclosure (magnetic member 12 is encapsulated within a protective material 68 such as titanium which is non-magnetic, para [0075]); and
the second magnetic member is encased in a second non-magnetic enclosure (magnetic member 14 is encapsulated within a protective material 68 such as titanium which is non-magnetic, para [0075]).
Claim(s) 1, 5, and 8 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 2009/0048618 (Harrison et al., hereinafter Harrison).
As to claim 1, Harrison discloses a device comprising:
a first magnetic member (see a first magnetic member 340 with magnet 342, Fig 21, para [0161]) configured to be mechanically coupled to a first bone in a patient (see how magnetic member 340 has a screw 336 in order to couple to a bone, Fig 21, para [0160]), the first bone having a first growth plate (a bone 330 will inherently have a growth plate, Fig 21); and
a second magnetic member (see a second magnetic member 344, Fig 21, para [0161]) configured to be implanted in the patient (344 also has a screw in order to implant it, para [0161]), wherein placement of the first and second magnetic members is chosen to modulate bone growth by exerting at least one of a compressive force and a tensile force across the first growth plate when mechanically coupled to the first bone and implanted in the patient respectively (see how members 340 and 344 have magnetic poles and thus can be positioned to exert a force across the growth plate depending on their positioning, Fig 21).
As to claim 5, Harrison discloses the device of claim 1, wherein the mechanical coupling comprises being mechanically attached to, but located outside of the first bone (see how a screw 336 mechanically couples 340 to the bone 330 but the magnet 342 is located outside of the bone, Fig 21, para [0160]).
As to claim 8, Harrison discloses the device of claim 5, wherein:
the first magnetic member is a tulip of a screw (see magnet 342 in casing 338 to form the tulip of a bone screw 336, Fig 21), the screw having the magnetic tulip (see how the tulip 342 is a magnet, Fig 21) and a non-magnetic shank (see non-magnetic shank 336, Fig 21, para [0160]); and
the non-magnetic shank is configured to be inserted into the first bone (see how shank 336 is inserted into bone 330, Fig 21).
Claim(s) 14 and 19 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 2005/0159754 (Odrich).
As to claim 14, Odrich discloses a method comprising:
mechanically coupling a first magnetic member (see magnetic member 112, Fig 15; magnet or attractor member 112, para [0054]) to a first bone in a patient (see how 112 is mechanically coupled to bone 108 via rods 114, ring 116, and the finger 102, Fig 15, para [0054]), the first bone having a first growth plate (bone 108 will inherently have a growth plate, Fig 15); and
implanting a second magnetic member (see second magnetic member 106, Fig 15; magnetically attractable sheet member 106, para [0054]) in the patient (see how 106 is implanted under soft tissue 110, Fig 15, para [0054]), wherein placement of the first and second magnetic members is chosen to modulate bone growth by exerting at least one of a compressive force and a tensile force across the first growth plate when coupled to the first bone and implanted within the patient respectively (magnet 112 attracts magnet 114 to exert a tensile force across the bone's growth plate to cause bone growth, Fig 21, para [0054]).
As to claim 19, Odrich discloses the method of claim 14, wherein mechanically coupling the first magnetic member to the first bone comprises mechanically attaching the first magnetic member to the first bone in a manner where the first magnetic member is located outside the first bone (see how magnetic member 112 is located outside of bone 108, Fig 15).
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.
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.
Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2005/0159754 (Odrich).
As to claim 15, Odrich discloses the method of claim 14, but does not explicitly teach:
implanting the second magnetic member in the patient comprises mechanically coupling the second magnetic member to a second bone, the second bone having a second growth plate; and
placement of the first and second magnetic members is chosen to modulate bone growth by exerting at least one of a compressive force and a tensile force across the second growth plate when coupled to the first bone and the second bone respectively.
Odrich further teaches where the magnets may be fixed to adjacent structures (para [0021]) and where the method of bone growth modulation may be applied to any condition requiring the growth of bone (the method may be applied to any condition requiring the growth of bone, para [0022]; for example see an embodiment with two magnets 126 and 128 coupled to bone segments 124 to cause an attractive force, Fig 17, para [0055]). Accordingly, it would have been obvious to a person having ordinary skill in the art, before the filing date of the claimed invention, to have utilized the system and teachings of Odrich as a whole to couple the second member to a second bone having a second growth plate in order to modulate bone growth of two separate bones (or bone segments) as needed by exerting a compressive or tensile force across the two growth plates based on the positioning of the magnets to correct a bone growth deformity.
Claim(s) 16-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2005/0159754 (Odrich) as applied to claim 14 above, and further in view of US 2005/0004417 (Nelson et al., hereinafter Nelson).
As to claim 16, Odrich discloses the method of claim 14, but does not explicitly teach wherein mechanically coupling the first magnetic member to the first bone comprises embedding the first magnetic member at least partially within the first bone. Nelson further teaches a first magnetic member (see first magnetic member 12, Fig 1; 12 comprises a permanent magnet, para [0066]) configured to be mechanically coupled to a first bone in a patient (12 can be fixated to a bone, para [0135]), wherein mechanically coupling the first magnetic member to the first bone comprises embedding the first magnetic member at least partially within the first bone (magnetic member 12 can include a screw and the device is a size that can be embedded in tissue, para [0133]; the tissue is a bone, para [0135]).
Accordingly, it would have been obvious to a person having ordinary skill in the art, before the filing date of the claimed invention, to modify the magnetic member of Odrich to be able to be embedded in bone as taught by Nelson in order to better fixate the magnetic member to the bone.
As to claim 17, Odrich and Nelson teach the method of claim 16, and Nelson further teaches wherein the first magnetic member is encased in a nonmagnetic enclosure (magnetic member 12 is encapsulated within a protective material 68 such as titanium which is non-magnetic, para [0075]).
As to claim 18, Odrich and Nelson teach the method of claim 17, and Nelson further teaches wherein the non-magnetic enclosure is made of titanium (protective material 68 is made of titanium, para [0075]).
Claim(s) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2005/0159754 (Odrich) as applied to claim 19 above, and further in view of US 2009/0048618 (Harrison et al., hereinafter Harrison).
As to claim 20, Odrich discloses the method of claim 19, but does not explicitly teach wherein:
the first magnetic member is a tulip of a screw, the screw having the magnetic tulip and a non-magnetic shank; and
the non-magnetic shank is inserted into the first bone.
Harrison further teaches a magnetic member (see magnetic member 340, Fig 21) where the magnet is a tulip of a screw (see magnet 342 in casing 338 to form the tulip of a bone screw 336, Fig 21) and the screw has a non-magnetic shank (see shank of bone screw 336 threaded into a bore 334, Fig 21, a bone screw has a non-magnetic shank, para [0160]) configured to be inserted into a bone (see bone screw 336 inserted in a vertebrae 330, Fig 21) where the magnetic member is used to correct a spinal deformity (an external magnet 360 is positioned with the same pole facing magnetic implant 340 to generate a repulsive force to reorient vertebrae 330, para [0163], vertebrae 330 is at the apex of abnormal curvature of the spine, para [0160]).
Accordingly, it would have been obvious to a person having ordinary skill in the art, before the filing date of the claimed invention, to modify the magnetic member of Odrich to be a tulip of a bone screw as taught by Harrison in order to use a standard bone screw to better fixate the magnetic member into bone to treat bone deformities.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOSHUA DARYL DEANON LANNU whose telephone number is (571)270-1986. The examiner can normally be reached Monday-Thursday 8 AM - 5 PM, Friday 8 AM -12 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Charles Marmor can be reached at (571) 272-4730. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JOSHUA DARYL D LANNU/Examiner, Art Unit 3791
/CARRIE R DORNA/Primary Examiner, Art Unit 3791