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 Rejections - 35 USC § 103
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.
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) 1-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over US Patent Application Publication No. 2018/0271572 A1 to Whyne et al. (Whyne) in view of US Patent Application Publication No. 2018/0368981 A1 to Mattes et al. (Mattes).
Regarding at least claim 1
Whyne teaches conformable chain mail devices for skeletal fixation, stabilization, and repair, and methods of manufacture and use thereof (abstract).
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Whyne meets the limitations of a medical product (fig. 3B, for example) for use in the treating a bone defect (the methods of using the device include stabilization of bone tissue, fixation of bone tissue, as a bone graft patch or as a thin bone tissue replacement; abstract), the medical product comprising a plurality of individual link elements which are connected to each other in such a way that adjacent individual link elements interlock/are linked to each other (paragraph 0039 discloses that the device comprises a plurality of interconnecting links which together form a strip or sheet of chain mail mesh), the individual link elements of the chain net being subdivided into main link elements and connection link elements (paragraph 0057 discloses that each link is generally a triangular, rectangular, hexagonal, or other polygonal shape and that the use of different shaped links will produce chain mail mesh having different conformability characteristics to allow the device to be tailored to particular uses – the examiner interprets a first shaped link to be the main link elements and a second shaped link to be the connection link elements; additionally, paragraph 0054 also discloses use of an end cap link/main link elements that is narrower than the square repeating links/connection link elements to limit movement of adjacent links so that they cannot flip over – shown in fig. 4A and fig. 4B), the connection link elements having a different geometric form than the main link elements (as disclosed in paragraph 0057, a first shaped link is interpreted as main link elements and a different shaped link is interpreted as connection link elements such that the links have a different geometric form and/or, as disclosed in paragraph 0054, the narrower end cap link/main link has a different geometric form than the square repeating link/connection link), the main link elements and the connection link elements forming a planar grid structure (paragraph 0006 discloses that the device comprises a conformable sheet of interconnected non-planar polygonal links that form a chain mail mesh) that extends in an x-direction, a y-direction and a z-direction, the planar grid structure in an x-y plane in an interlinked state (paragraph 0006 discloses that each interconnected non-planar polygonal link comprises planar surfaces that combine to form the first and second outer surfaces of the mesh which when said chain mail mesh is placed on a flat surface said first upper and second lower outer mesh surfaces are completely planar, respectively, of the conformable sheet), the x-y plane extending in the x-direction and the y-direction (as shown in fig. 3B, for example).
Whyne also teaches that the use of different shaped links will produce chain mesh having different conformability characteristics, for the purpose of allowing the device to be tailored to particular uses (paragraph 0057). However, Whyne does not teach wherein the main link elements have a first thickness in the z-direction and the connection link elements have a second thickness in the z-direction that is less than the first dimension.
Mattes teaches a medical product (100) for use in treating a bone cavity (abstract) that comprises a chain structure composed of interlocking members (110) (paragraph 0169 and fig. 2A, for example). In at least one embodiment, Mattes shows an additional structural element (190) arranged or integrated in a gap formed by interlocking members (110) that is configured to be larger than the members (110), for the purpose of stabilizing/stiffening the medical product without causing unintentional release of the additional structural elements (paragraph 0200).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the product of Whyne, which is used for treating and stabilizing bone, to specify that the main link elements are larger than the connection link elements, particularly in the z-direction such that they have a greater thickness, in order to stabilize/stiffen the medical product without causing unintentional release of the additional structural elements, as taught by Mattes.
Regarding at least claim 2
Whyne in view of Mattes teaches the medical product according to claim 1. Whyne also teaches wherein the main link elements are asymmetrical in the z- direction (paragraph 0049 discloses that each link is generally square shape defined by cuboid connecter beams that may have different depths – different depths of the beams would result in the structure being able to bend/curve/flex in a positive z-direction to a different degree than in a negative z-direction, i.e. asymmetrical in a z-direction; additionally paragraph 0053 discloses that the thickness and spacing of each link affects link mobility and influences the pliability of the mesh – therefore one of ordinary skill would recognize that pliability in a positive z-direction can be designed different than pliability in a negative z-direction; i.e. asymmetrical in a z-direction, if desired).
Regarding at least claim 3
Whyne in view of Mattes teaches the medical product according to claim 1. Whyne also teaches the medical product according to claim 3, wherein the planar grid structure is curvable in the z-direction (paragraph 0002 discloses that a high degree of conformability is required to mimic the natural curvature of complex bone structures and paragraph 0017 discloses conforming the structural device to an anatomical shape by taking advantage of the conformability of the chain mail mesh – therefore the device is curvable in the z-direction in order to conform to an anatomical shape).
Regarding at least claim 4
Whyne in view of Mattes teaches the medical product according to claim 1. Whyne also teaches the medical product according to claim 4, wherein the main link elements predefine a maximum curvature of the planar grid structure by their mutual contact (paragraph 0053 discloses the range of movement for a link is determined by the amount of free space around the link to which it is connected and that the thickness of each link can also affect the range of motion between interconnected links – therefore, the spacing and thickness of the main links predefine a maximum curvature of the planar grid structure by their mutual contact as claimed).
Regarding at least claim 5
Whyne in view of Mattes teaches the medical product according to claim 1. Whyne also teaches the medical product according to claim 5, wherein the connection link elements prevent movement of the main Page 3 of 8Appln. No.: TBDAttorney Docket No.: AAG-353USAmendment Dated: May 27, 2021link elements upon reaching the predefined maximum curvature (paragraph 0054 discloses that the end cap link components/connection link elements limit/prevent movement of the adjacent, interconnected links so that they cannot flip over).
Regarding at least claim 6
Whyne in view of Mattes teaches the medical product according to claim 1. Whyne also teaches the medical product according to claim 6, wherein the predefined maximum curvature in a positive z-direction is different from the maximum curvature in a negative z-direction (paragraph 0049 discloses that each link is generally square shape defined by cuboid connecter beams that may have different depths – different depths of the beams would result in the structure being able to bend/curve/flex in a positive z-direction to a different degree than in a negative z-direction, i.e. asymmetrical in a z-direction; additionally paragraph 0053 discloses that the thickness and spacing of each link affects link mobility and influences the pliability of the mesh – therefore one of ordinary skill would recognize that pliability in a positive z-direction can be designed different than pliability in a negative z-direction; i.e. asymmetrical in a z-direction, if desired).
Regarding at least claim 7
Whyne in view of Mattes teaches the medical product according to claim 1. Whyne also teaches wherein the main link elements are each formed as a framework-shaped, triangular frustum of a pyramid (paragraph 0008 discloses links that are pyramidal and are shaped as a framework having a triangular frustum) and the connection link elements are each formed as an eyelet-shaped polygon (paragraph 0057 discloses hexagonal shaped links that are formed as eyelet-shaped polygons as claimed, particularly in view of page 6 of applicant’s disclosure which states that the eyelet-shaped polygon is a hexagon).
Regarding at least claim 8
Whyne in view of Mattes teaches the medical product according to claim 1. Whyne also teaches the medical product according to claim 7, wherein the connection link elements are each formed as an eyelet- shaped hexagon (paragraph 0057 discloses hexagonal shaped links that are formed as eyelet-shaped polygons as claimed, particularly in view of page 6 of applicant’s disclosure which states that the eyelet-shaped polygon is a hexagon).
Regarding at least claim 9
Whyne in view of Mattes teaches the medical product according to claim 1. Whyne also teaches the medical product according to claim 1, wherein the main link elements and the connection link elements have a self-contained shape (each polygonal link has a self-contained shape as shown in fig. 1C).
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Regarding at least claim 10
Whyne in view of Mattes teaches the medical product according to claim 1. Whyne also teaches that the connection link elements are shown to be U-shapes that form a complete linkage with an overall square profiled (paragraph 0020). The connection link elements are shown to have a common orientation and be conforming to a common first plane (fig. 3A shows a common orientation of the connection link elements and annotated fig. 2B shows a common plane defined by a surface of the connection link elements).
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Whyne also discloses the use of different shaped links will produce chain mail mesh having different conformability characteristics to allow the device to be tailored to particular uses (paragraph 0057). However, Whyne does not teach that the connection link elements comprise rings.
There is no evidence of record that establishes that changing the formation of the connection link elements to comprise rings would result in a difference in function of the Whyne device. Further, a person having ordinary skill in the art, being faced with modifying the formation of the connection link elements of Whyne to comprise rings, would have a reasonable expectation of success in making such a modification and it appears the device would function as intended being given the claimed formation since they are a self-contained shape with an opening defined by a closed border. Lastly, applicant has not disclosed that the claimed connection link elements that comprise rings solves any stated problem, indicating that the connection link elements are exemplarily formed as an eyelet-shaped hexagon, and offering other acceptable formations (e.g., formed as a dome-shaped grid shell [page 6, lines 4-15 ]) and therefore there appears to be no criticality placed on the shape as claimed such that it produces an unexpected result.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the connection link element of Whyne to comprise rings as an obvious matter of design choice within the skill of the art.
Regarding at least claim 11
Whyne in view of Mattes teaches the medical product according to claim 10. Whyne also teaches wherein the common first plane extends in the x-direction and the y-direction (fig. 3A shows that the common first plane to which the connection link elements are conformed extends in the x-direction and the y-direction).
Regarding at least claim 12
Whyne in view of Mattes teaches the medical product according to claim 11. Whyne also teaches wherein each main link element is formed as a framework comprising a first polygon and a second polygon parallel to and offset from the first polygon (annotated fig. 4A shows two polygons that are parallel to and offset from one another).
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Regarding at least claim 13
Whyne in view of Mattes teaches the medical product according to claim 12. Whyne also teaches wherein the first polygons of the main link elements conform to a common second plane, and the second polygons of the main link elements conform to a common third plane (annotated fig. 4A roughly shows the common first, second, and third planes with a dashed line indicating the surface of the plane; each of the polygons conform to a common second plane and a common third plane are is therefore construed to meet the limitation as claimed).
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Regarding at least claim 14
Whyne in view of Mattes teaches the medical product according to claim 12. Whyne also teaches wherein the common second plane and the common third plane extend in the x-direction and the y-direction (each of the planes to which the polygons conform extend in the x and y directions as shown in fig. 4A, for example).
Regarding at least claim 15
Whyne in view of Mattes teaches the medical product according to claim 14. Whyne also teaches wherein the common first plane extends between the common second plane and the common third plane (annotated fig. 4A above shows that the common first plane extends between the common second and common third planes).
Regarding at least claim 16
Whyne teaches conformable chain mail devices for skeletal fixation, stabilization, and repair, and methods of manufacture and use thereof (abstract).
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Whyne meets the limitations of a medical product (fig. 3B, for example) for use in the treating a bone defect (the methods of using the device include stabilization of bone tissue, fixation of bone tissue, as a bone graft patch or as a thin bone tissue replacement; abstract), the medical product comprising a plurality of individual link elements which are connected to each other in such a way that adjacent individual link elements interlock/are linked to each other (paragraph 0039 discloses that the device comprises a plurality of interconnecting links which together form a strip or sheet of chain mail mesh), the individual link elements being subdivided into main link elements and connection link elements (paragraph 0057 discloses that each link is generally a triangular, rectangular, hexagonal, or other polygonal shape and that the use of different shaped links will produce chain mail mesh having different conformability characteristics to allow the device to be tailored to particular uses – the examiner interprets a first shaped link to be the main link elements and a second shaped link to be the connection link elements; additionally, paragraph 0054 also discloses use of an end cap link/main link elements that is narrower than the square repeating links/connection link elements to limit movement of adjacent links so that they cannot flip over – shown in fig. 4A and fig. 4B), the main link elements and the connection link elements forming a planar grid structure (paragraph 0006 discloses that the device comprises a conformable sheet of interconnected non-planar polygonal links that form a chain mail mesh) being planar in an x-direction, a y-direction and a z-direction, the planar grid structure in an x-y plane in an interlinked state (paragraph 0006 discloses that each interconnected non-planar polygonal link comprises planar surfaces that combine to form the first and second outer surfaces of the mesh which when said chain mail mesh is placed on a flat surface said first upper and second lower outer mesh surfaces are completely planar, respectively, of the conformable sheet), the x-y plane extending in the x-direction and the y-direction (as shown in fig. 3B, for example).
Whyne also teaches that the use of different shaped links will produce chain mesh having different conformability characteristics, for the purpose of allowing the device to be tailored to particular uses (paragraph 0057). However, Whyne does not teach wherein the main link elements have a first thickness in the z-direction and the connection link elements have a second thickness in the z-direction that is less than the first dimension.
Mattes teaches a medical product (100) for use in treating a bone cavity (abstract) that comprises a chain structure composed of interlocking members (110) (paragraph 0169 and fig. 2A, for example). In at least one embodiment, Mattes shows an additional structural element (190) arranged or integrated in a gap formed by interlocking members (110) that is configured to be larger than the members (110), for the purpose of stabilizing/stiffening the medical product without causing unintentional release of the additional structural elements (paragraph 0200).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the product of Whines, which is used for treating and stabilizing bone, to specify that the main link elements are larger than the connection link elements, particularly in the z-direction such that they have a greater thickness, in order to stabilize/stiffen the medical product without causing unintentional release of the additional structural elements, as taught by Mattes.
Whyne also teaches that the connection link elements are shown to be U-shapes that form a complete linkage with an overall square profiled (paragraph 0020). The connection link elements are shown to have a common orientation and be conforming to a common first plane (fig. 3A shows a common orientation of the connection link elements and annotated fig. 2B shows a common plane defined by a surface of the connection link elements).
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Whyne also discloses the use of different shaped links will produce chain mail mesh having different conformability characteristics to allow the device to be tailored to particular uses (paragraph 0057). However, Whyne does not teach that the connection link elements comprise rings.
There is no evidence of record that establishes that changing the formation of the connection link elements to comprise rings would result in a difference in function of the Whyne device. Further, a person having ordinary skill in the art, being faced with modifying the formation of the connection link elements of Whyne to comprise rings, would have a reasonable expectation of success in making such a modification and it appears the device would function as intended being given the claimed formation since they are a self-contained shape with an opening defined by a closed border. Lastly, applicant has not disclosed that the claimed connection link elements that comprise rings solves any stated problem, indicating that the connection link elements are exemplarily formed as an eyelet-shaped hexagon, and offering other acceptable formations (e.g., formed as a dome-shaped grid shell [page 6, lines 4-15 ]) and therefore there appears to be no criticality placed on the formation as claimed such that it produces an unexpected result.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the connection link element of Whyne to comprise rings as an obvious matter of design choice within the skill of the art.
Regarding at least claim 17
Whyne in view of Mattes teaches the medical product according to claim 11. Whyne also teaches wherein each main link element is formed as a framework comprising a first polygon and a second polygon parallel to and offset from the first polygon (annotated fig. 4A shows two polygons that are parallel to and offset from one another).
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Regarding at least claim 18
Whyne in view of Mattes teaches the medical product according to claim 12. Whyne also teaches wherein the first polygons of the main link elements conform to a common second plane, and the second polygons of the main link elements conform to a common third plane (annotated fig. 4A roughly shows the common first, second, and third planes with a dashed line indicating the surface of the plane; each of the polygons conform to a common second plane and a common third plane are is therefore construed to meet the limitation as claimed).
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Regarding at least claim 19
Whyne in view of Mattes teaches the medical product according to claim 14. Whyne also teaches wherein the common first plane extends between the common second plane and the common third plane (annotated fig. 4A above shows that the common first plane extends between the common second and common third planes).
Regarding at least claim 20
Whyne in view of Mattes teaches the medical product according to claim 17. Whyne also teaches in alternative embodiments, each link is generally triangular, for the purpose of producing chain mail mesh having different conformability characteristics (paragraph 0057).
It would have been obvious to modify the links such that the first polygon comprises a first triangle and the second polygon comprises a second triangle, in order to produce chain mail mesh having different conformability characteristics, as taught by Whyne.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MELISSA A HOBAN whose telephone number is (571)270-5785. The examiner can normally be reached Monday-Friday 8:00AM-5:00PM.
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.
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/M.A.H/Examiner, Art Unit 3774
/SARAH W ALEMAN/Primary Examiner, Art Unit 3774
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