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
Applicant’s election of Species A in the reply filed on May 12th, 2025 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 10-17 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention and/or species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on May 12th, 2025.
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.
Claims 1- 5 are rejected under 35 U.S.C. 103 as being unpatentable over Chegini (U.S. Publication 2013/0226251) in view of Lorio (U.S. Publication 2015/0313720).
Chegini discloses a device (for example see Figure 2) comprising:
(claim 1) a threadless solid first lengthwise end (20) including
(claim 1) a conical penetrating edge comprising a point adapted for penetration and insertion into and through an opening in a bone (for example see paragraphs 32-33)
(claim 1) a solid second lengthwise end (48) comprising a non-penetrating margin position oppose the conical penetrating edge (for example see Figure 6)
(claim 1) a first section proximate the threadless solid first lengthwise end (12)
(claim 1) a second section proximate the solid second lengthwise end (50)
(claim 1) wherein the first and second sections are rigid construction (the device is capable of being driven by a hammer as discussed in paragraph 41 and can therefore be interpreted as “rigid”)
(claim 1) a flexible mesh section (18) comprising an unobstructed inner volume (the volume of the mesh is unobstructed and is capable allowing things to pass through) including
(claim 1) a first circumference connected to an inward side (64) of the first lengthwise end (see Figure 3A)
(claim 1) a second circumference connected to an inward side (66) of the second lengthwise end (see Figure 3A)
(claim 1) a plurality of interwoven wires or fibers between the first circumference and the second circumference
(claim 1) the interwoven wires or fibers creating apertures (the closed cells between the wires or fibers)
(claim 1) wherein prior to insertion through an opening a middle cross-section of the flexible mesh is equal to or less than diameters of the inward side of the threadless solid lengthwise ends (see Figure 3A)
(claim 1) wherein after insertion through an opening the middle cross-section of the flexible mesh expands to a size larger than the size of a bore of the opening capable of preventing pullout from a bone
Chegini fails to disclose the wherein the flexible mesh structure comprises a plurality of interwoven shape memory wires or polymer fibers (claim 1), the interwoven mesh creating apertures having a size from 1 micrometer to 5 millimeters (claim 1), the middle cross-section of the mesh having an expanded size at least two times the size of a bore for an opening (claim 1), wherein a transition temperature for the mesh is influenced by the shape memory (claim 2), wherein the mesh comprises at least one shape memory alloy or shape memory polymer (claim 3), such as nickel and titanium (claim 4), wherein the transition temperature causes expansion and contraction of the mesh (claim 5), wherein the transition temperature is about 20 to 33 degrees Celsius (claim 6) or less than about 35 degrees Celsius.
Regarding the mesh comprising a plurality of shape memory wires or polymer fibers (claims 1-7), Lorio teaches a device comprising a first end, a second end, and a flexible mesh section (160; paragraph 43) (for example see Figure 1) including interwoven shape memory wires or fibers made from nickel and titanium (paragraph 53) creating apertures between the wires or fibers, wherein the transition temperature of the shape memory material causes expansion and contraction of the mesh (this is how shape memory materials work). It would have been obvious to one having ordinary skill in the art at the time the invention was filed to provide the device of Chegini wherein the flexible mesh structure is made from shape memory wires or fibers in view of Lorio, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
Regarding the apertures of the mesh being 1 micrometer to 5 millimeters, it would have been obvious to one having ordinary skill in the art at the time the invention was filed to provide the device of Chegini as modified by Lorio wherein the aperture of the mesh be 1 micrometer to 5 millimeters, since it has been held that where the general conditions of a claim are disclosed in the prior art, i.e. the device including a mesh section made from wires or fibers having apertures formed in the mesh section, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Regarding the middle cross-section of the mesh having an expanded size at least twice the size of a bore of an opening, it would have been obvious to one having ordinary skill in the art at the time the invention was filed to provide the device of Chegini as modified by Lorio the middle cross-section of the mesh having an expanded size at least twice the size of a bore of an opening, since it has been held that where the general conditions of a claim are disclosed in the prior art, i.e. the device including a mesh section having an expanded size while in the bore of an opening, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Regarding the transition temperature being from about 20 degrees Celsius to about 33 degrees Celsius, i.e. less than about 35 degrees Celsius, it would have been obvious to one having ordinary skill in the art at the time the invention was filed to provide the device of Chegini as modified by Lorio wherein the transition temperature for the shape memory material is about 20 degrees Celsius to about 33 degrees Celsius, i.e. less than about 35 degrees Celsius, since it has been held that where the general conditions of a claim are disclosed in the prior art, i.e. the device including a mesh section made from a shape memory material having a transition temperature, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Chegini (U.S. Publication 2013/0226251) in view of Lorio (U.S. Publication 2015/0313720) further in view of Hochschuler (U.S. Publication 2010/0217325).
The device of Chegini as modified by Lorio discloses the invention as claimed except for the non-penetrating margin having a polyaxial head. Hochschuler teaches a device comprising a first end including a non-penetrating margin (119), wherein the non-penetrating margin further includes a polyaxial head (118; for example see Figures 22 and 24) in order to couple other elements to the device. It would have been obvious to one having ordinary skill in the art at the time the invention was filed to provide the device of Chegini as modified by Lorio wherein the non-penetrating margin further includes a polyaxial head in view of Hochschuler in order to couple other elements to the device.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Chegini (U.S. Publication 2013/0226251) in view of Lorio (U.S. Publication 2015/0313720) further in view of Chirico (U.S. Publication 2009/0276048).
The device of Chegini as modified by Lorio discloses the invention as claimed except for the device comprising one or more areas having a surface treatment. Chirico teaches a device comprising one or more areas including a surface treatment (paragraph 86) in order to promote or inhibit bone growth. It would have been obvious to one having ordinary skill in the art at the time the invention was filed to provide the device of Chegini as modified by Lorio wherein the device further comprises at least one or more area having a surface treatment in view of Chirico in order to promote or inhibit bone growth.
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