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 § 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) 1-3, 5, 9, 11, and 15 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Mickiewicz et al. (US 2008/0255622; “Mickiewicz”).
Claim 1, Mickiewicz discloses a method (Figs. 15-16A) of affixing two bone segments in or near approximation with one another (200, 202), the method comprising implanting a bone staple (Fig. 5; 60), the bone staple comprising a crown (62) and a plurality of legs (64, 66) of differing lengths (paragraphs [0044]-[0049]), at least some of the legs having a first length and at least some of the legs having a different second length (Fig. 5; paragraphs [0044]-[0049]), wherein at least one leg having a first length and at least one leg having a second length are implanted in each of the two bone segments (Figs. 15-16A; paragraphs [0073]-[0074]).
Claim 2, Mickiewicz discloses the method of claim 1, further comprising applying compression in the bone segments (Figs. 5 and 15-16A; paragraphs [0073]-[0074]; note how the screw is threaded into the bone so the threads are compressing and cutting bone, while the screw at the same time maintains a particular separation of the bones and the tines pierce into the bone which will cause the bone to compress and the tines are holding the bones in place in relation to the device).
Claim 3, Mickiewicz discloses the method of claim 2, wherein the compression is applied by an obliquely inclined bevel on at least one of the legs engaging at least one of the bone segments as the bone staple is implanted (Figs. 5 and 15-16A; note the shape of the bevel on the tines, just like the Applicant’s device, furthermore, the PTAB confirmed this shape will result in this function required by this claim, see Board decision in Application 16/999474).
Claim 5, Mickiewicz discloses the method of claim 1, wherein the plurality of legs of the bone staple are resiliently flexible relative to the crown portion and each comprise an inwardly-directed and obliquely-inclined bevel, whereby contact between the obliquely-inclined bevels and the bone segments imparts a diverging directional force on the plurality of legs, causing the plurality of legs to elastically flex outwardly and effect inward compression of the bone segments (Fig. 5; this feature was confirmed to be disclosed by Mickiewicz in the parent Application 16/999474, see PTAB decision).
Claim 9, Mickiewicz discloses the method of claim 1, wherein the step of implanting the bone staple comprises insertion of a bone screw (Fig. 15; 14) through an opening in the crown portion of the bone staple and driving the bone screw into at least one of the bone segments (Figs. 15-16A).
Claim 11, Mickiewicz discloses a method of affixing two bone segments in or near approximation with one another (Figs. 15-16A), the method comprising: applying a first portion of a bone staple to a first bone segment and a second portion of the bone staple to a second bone segment (Fig. 16; paragraphs [0073]-[0074]), the bone staple comprising a crown portion (Fig. 5; 62) and a plurality of legs (64, 66) extending from the crown portion (Fig. 5), at least one of the plurality of legs comprising the first portion of the bone staple, and at least another of the plurality of legs comprising the second portion of the bone staple (Fig. 5), wherein the plurality of legs are resiliently flexible relative to the crown portion and each comprise an inner surface directed inwardly toward a central axis (Fig. 5; the structure and functionality of the legs were prosecuted and confirmed in parent Application 16/999474 by the PTAB), a pointed tip (Fig. 5), and at least one inwardly-directed and obliquely-inclined bevel (Fig. 5); driving the bone staple to embed at least one obliquely-inclined bevel of the first portion of the bone staple to the first bone segment and to embed at least one obliquely-inclined bevel of the second portion of the bone staple to the second bone segment, whereby contact between the obliquely-inclined bevels and the first and second bone segments imparts a diverging directional force on the plurality of legs, causing the plurality of legs to elastically flex outwardly relative to the central axis to effect compression of the first and second bone segments inwardly toward the central axis (Figs. 5 and 15-16A; paragraphs [0073]-[0074]; note the shape of the bevel on the tines, just like the Applicant’s device, furthermore, the PTAB confirmed this shape will result in this function required by this claim, see Board decision in Application 16/999474).
Claim 15, Mickiewicz discloses the method of claim 11, wherein the step of driving the bone staple to embed at least one obliquely-inclined bevel of the first portion of the bone staple to the first bone segment and to embed at least one obliquely-inclined bevel of the second portion of the bone staple to the second bone segment comprises insertion of a bone screw (Fig. 15; 14) through an opening in the crown portion of the bone staple and driving the bone screw into at least one of the first and second bone segments (Figs. 15-16A).
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(s) 6 and 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mickiewicz et al. (US 2008/0255622; “Mickiewicz”), in view of Goble et al. (US 5314427; “Goble”).
Claim 6, Mickiewicz discloses the method of claim 1.
However, Mickiewicz does not disclose using a mallet to help insert the staple.
Goble teaches a method of inserting a staple into bone (Fig. 4; abstract) wherein the bone staple is implanted into bone using a mallet to tap the bone staple into the bone (Fig. 4; col. 4, lines 24-34).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to use a mallet, as taught by Goble, in the method of Mickiewicz, in order to help drive the tines into the bone (col. 4, lines 24-34).
Claim 12, Mickiewicz discloses the method of claim 11.
However, Mickiewicz does not disclose using a mallet to help insert the staple.
Goble teaches a method of inserting a staple into bone (Fig. 4; abstract) wherein the bone staple is implanted into bone using a mallet to tap the bone staple into the bone (Fig. 4; col. 4, lines 24-34).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to use a mallet, as taught by Goble, in the method of Mickiewicz, in order to help drive the tines into the bone (col. 4, lines 24-34).
Claim(s) 7-8 and 13-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mickiewicz et al. (US 2008/0255622; “Mickiewicz”), in view of Anthony et al. (US 2013/0261629; “Anthony”).
Claim 7, Mickiewicz discloses the method of claim 1.
However, Mickiewicz does not disclose using a punch tool.
Anthony teaches a method of inserting a bone implant (abstract) comprising application of a punch tool (Fig. 14) to form pilot holes in the bone segments, the punch tool comprising teeth having a tooth pattern corresponding to a tip pattern of the plurality of legs (Fig. 14 and 29-33).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to include the punch with multiple legs matching the number of legs of the implant, as taught by Anthony, to the method of Mickiewicz, in order to prepare the bone for the implant (paragraph [0087]).
Claim 8, Mickiewicz discloses the method of claim 1.
However, Mickiewicz does not disclose using a drill template to drill multiple holes.
Anthony teaches using a drill template to drill pilot holes in the bone segments, the drill template comprising template openings having template opening pattern corresponding to a tip pattern of the plurality of legs (Fig. 31; paragraph [0094]).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to combine a drill template, as taught by Anthony, to the method of Mickiewicz, in order to prepare the bone for the implant (paragraph [0094]).
Claim 13, Mickiewicz discloses the method of claim 11.
However, Mickiewicz does not disclose using a punch tool.
Anthony teaches a method of inserting a bone implant (abstract) comprising application of a punch tool (Fig. 14) to form pilot holes in the bone segments, the punch tool comprising teeth having a tooth pattern corresponding to a tip pattern of the plurality of legs (Fig. 14 and 29-33).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to include the punch with multiple legs matching the number of legs of the implant, as taught by Anthony, to the method of Mickiewicz, in order to prepare the bone for the implant (paragraph [0087]).
Claim 14, Mickiewicz discloses the method of claim 11.
However, Mickiewicz does not disclose using a drill template to drill multiple holes.
Anthony teaches using a drill template to drill pilot holes in the bone segments, the drill template comprising template openings having template opening pattern corresponding to a tip pattern of the plurality of legs (Fig. 31; paragraph [0094]).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to combine a drill template, as taught by Anthony, to the method of Mickiewicz, in order to prepare the bone for the implant (paragraph [0094]).
Claim(s) 10 and 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mickiewicz et al. (US 2008/0255622; “Mickiewicz”), in view of Miller et al. (US 2014/0277516; “Miller”).
Claim 10, Mickiewicz discloses the method of claim 1, wherein some type of method to get the right sized staple is used.
However, Mickiewicz does not disclose exactly what they use to determine the proper size.
Miller teaches a method of implanting a bone staple (abstract) comprising using a sizer to determine an appropriate size of the bone staple for the intended procedure of affixing the two bone segments in approximation with one another (Figs. 1-6; paragraphs [0031]-[0032]).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to include a sizer, as taught by Miller, to the method of Mickiewicz, in order to figure out the proper size staple to use (paragraphs [0031]-[0032]).
Claim 16, Mickiewicz discloses the method of claim 11, wherein some type of method to get the right sized staple is used.
However, Mickiewicz does not disclose exactly what they use to determine the proper size.
Miller teaches a method of implanting a bone staple (abstract) comprising using a sizer to determine an appropriate size of the bone staple for the intended procedure of affixing the two bone segments in approximation with one another (Figs. 1-6; paragraphs [0031]-[0032]).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to include a sizer, as taught by Miller, to the method of Mickiewicz, in order to figure out the proper size staple to use (paragraphs [0031]-[0032]).
Claim(s) 18 and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mickiewicz et al. (US 2008/0255622; “Mickiewicz”), in view of Miller et al. (US 2014/0277516; “Miller”), in further view of Anthony et al. (US 2013/0261629; “Anthony”).
Claim 18, Mickiewicz discloses a method of affixing a first bone segment in or near approximation with a second bone segment (Figs. 15-16A), the method comprising: a bone staple (Fig. 5) comprising a crown portion (62) and a plurality of legs (64, 66) extending from the crown portion (Fig. 5), wherein the plurality of legs are resiliently flexible relative to the crown portion and each comprise a tip portion having at least one inwardly-directed and obliquely-inclined bevel Fig. 5; note the shape of the bevel on the tines, just like the Applicant’s device, furthermore, the PTAB confirmed this shape will result in this function required by this claim, see Board decision in Application 16/999474)); driving the bone staple to embed at least the tip portion of at least one of the plurality of legs into a first bone segment and to embed at least the tip portion of another of the plurality of legs into the second bone segment, whereby contact between the obliquely-inclined bevels of the tip portions and the first and second bone segments imparts a diverging directional force on the plurality of legs, causing the plurality of legs to elastically flex outwardly relative and thereby effect inward compression between the first and second bone segments (Figs. 5 and 15-16A; paragraphs [0073]-[0074]; note how the screw is threaded into the bone so the threads are compressing and cutting bone, while the screw at the same time maintains a particular separation of the bones and the tines pierce into the bone which will cause the bone to compress and the tines are holding the bones in place in relation to the device).
However, Mickiewicz does not disclose exactly what they use to determine the proper size.
Miller teaches a method of implanting a bone staple (abstract) comprising using a sizer to determine an appropriate size of the bone staple for the intended procedure of affixing the two bone segments in approximation with one another (Figs. 1-6; paragraphs [0031]-[0032]).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to include a sizer, as taught by Miller, to the method of Mickiewicz, in order to figure out the proper size staple to use (paragraphs [0031]-[0032]).
Mickiewicz in view of Miller disclose the method as noted above.
However, they do not disclose forming pilot holes.
Anthony teaches a method of inserting a bone implant (abstract) comprising application of a punch tool (Fig. 14) to form pilot holes in the bone segments, the punch tool comprising teeth having a tooth pattern corresponding to a tip pattern of the plurality of legs (Fig. 14 and 29-33).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to include the punch with multiple legs matching the number of legs of the implant, as taught by Anthony, to the method of Mickiewicz in view of Miller, in order to prepare the bone for the implant (paragraph [0087]).
Claim 20, Mickiewicz in view of Miller and Anthony disclose the method of claim 18, Mickiewicz discloses wherein the step of driving the bone staple comprises insertion of a bone screw (Fig. 5; 14) through an opening in the crown portion of the bone staple and driving the bone screw into at least one of the first and second bone segments (Figs. 15-16A).
Claim(s) 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mickiewicz et al. (US 2008/0255622; “Mickiewicz”), in view of Miller et al. (US 2014/0277516; “Miller”), in further view of Anthony et al. (US 2013/0261629; “Anthony”), in further view of Goble et al. (US 5314427; “Goble”).
Claim 19, Mickiewicz in view of Miller and Anthony discloses the method of claim 18.
However, they do not disclose using a mallet to help insert the staple.
Goble teaches a method of inserting a staple into bone (Fig. 4; abstract) wherein the bone staple is implanted into bone using a mallet to tap the bone staple into the bone (Fig. 4; col. 4, lines 24-34).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to use a mallet, as taught by Goble, in the method of Mickiewicz in view of Miller and Anthony, in order to help drive the tines into the bone (col. 4, lines 24-34).
Allowable Subject Matter
Claims 4 and 17 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Claims 4 and 17 requires the method of using a bone staple to affix two bone segments and then placing an articulation wire through an opening in the crown and around one of the legs of the staple to apply a compressive force (Applicant’s Figs. 13-15). This feature is not shown in the cited prior art and it would not be obvious to combine this feature, in combination with the other claim limitations, to the prior art used in the rejections above.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Zade Coley whose telephone number is (571)270-1931. The examiner can normally be reached M-F (9-5) PT.
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/Zade Coley/Primary Examiner, Art Unit 3775