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 .
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.
Claim Objections
Claim 2 objected to because of the following informalities: There is a typographical error - “where in” should read “wherein”. Appropriate correction is required.
Claim 6 objected to because of the following informalities: There is a typographical error - “seat” should read “sit”. Appropriate correction is required.
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.
Claim 4 is 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 retention member" in line 10. There is insufficient antecedent basis for this limitation in the claim. For examination purposes, this is being interpreted as “further comprising a retention member comprising a tissue anchor passing into and through the transverse bore.”
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, 12 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Visotsky (20020038123).
Regarding claim 1, Visotsky discloses a dowel fusion system, comprising a frustoconical dowel (10; FIG 1) made of a biocompatible material ([0026]) and configured to be placed within a tapered bore between longitudinally adjacent resected bones and allow for fixation of the longitudinally adjacent resected bones ([0008]).
Regarding claim 2, Visotsky discloses the dowel fusion system of Claim 1, wherein the biocompatible material is selected from the group of autograft, allograft ([0030]. Note that the prior art does not need to disclose the limitation “synthetic bone graft substitute, metal, and/or nickel-titanium based shape memory alloys” to meet the claimed invention since the claim recites the limitations in the alternative only using the term “and/or”).
Regarding claim 3, Visotsky discloses the dowel fusion system of Claim 1, wherein the frustoconical dowel further comprises a transverse bore (50) passing laterally through the frustoconical dowel (FIG 1).
Regarding claim 12, Visotsky discloses the dowel fusion system of Claim 1, wherein the dowel is configured to be implanted into an intercuneiform joint (the phrase “configured to be implanted into an intercuneiform joint” is treated as functional language that is given limited patentable weight. The prior art is not required to disclose this function, but merely have the capability of the performing the function, in order to meet the claim requirement. Given that Visotsky discloses the structure of the dowel as claimed, it is capable of being implanted into an intercuneiform joint as claimed).
Claim(s) 1 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Neal (20160128701).
Regarding claim 1, Neal discloses a dowel fusion system, comprising a frustoconical dowel (200””; FIG 5G) made of a biocompatible material ([0086-0087]) and configured to be placed within a tapered bore between longitudinally adjacent resected bones and allow for fixation of the longitudinally adjacent resected bones ([00163]).
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Visotsky as applied to claim 3 above, and further in view of Chandran (6579293).
Regarding claim 4, Visotsky discloses the dowel fusion system of Claim 3, but fails to disclose wherein the retention member further comprises a tissue anchor passing into and through the transverse bore.
Chandran also discloses a dowel (110) with a transverse bore (119), and teaches a tissue anchor retention member (132) passing into and through the transverse bore ([col 6, line 20]). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Visotsky to include that the retention member further comprises a tissue anchor passing into and through the transverse bore, as taught by Chandran, in order to have more stable and reliable fixation of the bones (col 3, line 38).
Claim(s) 5-7, 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Neal as applied to claim 1 above, and further in view of Hartdegen (20180353172).
Regarding claim 5, Neal discloses the dowel fusion system of Claim 1, but fails to disclose wherein the frustoconical dowel further comprises a recess formed in a proximal surface of the frustoconical dowel and extending diametrically across the proximal surface.
Hartdegen also discloses a dowel (150; FIG 3A) made of biocompatible material and configured to be placed between and allow for fixation of longitudinally adjacent bones (4, 6, FIG 8A). Hartdegen teaches that the dowel comprises a recess (164) formed in a proximal surface of the dowel and extending diametrically across the proximal surface ( FIG 3A). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Neal to include that the dowel comprises a recess formed in a proximal surface of the dowel and extending diametrically across the proximal surface, as taught by Hartdegen, in order to allow a clip to be inserted to prevent rotation of the dowel once inserted and therefore of the bone portions ([00107]).
Regarding claim 6, Neal as modified by Hartdegen discloses the dowel fusion system of Claim 5, but fails to disclose that it further comprises a retention member configured to seat in the recess in the proximal surface of the frustoconical dowel.
Hartdegen further teaches a retention member (200, FIG 2A) configured to seat in the recess (164) in the proximal surface of the dowel ([103]). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Neal to include a retention member configured to seat in the recess in the proximal surface of the frustoconical dowel as further taught by Hartdegen, in order to prevent rotation of the dowel once inserted and therefore of the bone portions ([00107]).
Regarding claim 7, Neal as modified by Hartdegen discloses the dowel fusion system of Claim 6, wherein the retention member further comprises a staple (200; see Fig. 2A).
Regarding claim 9, Neal as modified by Hartdegen discloses the dowel fusion system of Claim 6, and further that the retention member (200) further comprises anchor projections (202, 204) associated with the dowel (since as modified, 200 sits in the in the recess 164 in the proximal surface of the dowel) and configured to engage the longitudinally adjacent resected bones ([00100]).
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Neal in view of Hartdegen as applied to claim 6 above, and further in view of Shepard (20040078078).
Regarding claim 8, Neal as modified by Hartdegen discloses the dowel fusion system of Claim 6, and further that the retention member(200) comprises a plate (206). Neal as modified by Hartdegen fails to disclose tissue anchor openings at opposing ends of the plate.
Shepard also discloses a dowel (12) configured to be placed between longitudinally adjacent bones ([0078])) having a recess (16) and a retention member (30) configured to sit in the recess (Figs. 1, 3, 7). Shepard teaches that the retention member (30) comprises tissue anchor openings (44, 46) at opposing ends of the plate (Fig. 7). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have further modified the plate of the retention member of Neal in view of Hartdegen to include tissue anchor openings at opposing ends of the plate, as taught by Shepard, in order to provide additional stability to the graft ([0063]).
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Visotsky as applied to claim 1 above, and further in view of Neal (20160128701) and Boyer (20010039457).
Regarding claim 10, Visotsky discloses the dowel fusion system of Claim 1, but fails to disclose wherein the biocompatible material is porous metal and the dowel is configured as a mosaic structure.
Neal also discloses a dowel (100) for foot and ankle fusion (FIG 3C) made of biocompatible material (1000). Neal teaches the biocompatible material (1000) is porous metal ([0088], “porous tantalum material). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Visotsky’s dowel to be made of a biocompatible porous metal, as taught by Neal, in order to provide a dowel substantially uniform and consistent in composition and closely resembling the structure of natural cancellous bone, thereby providing a matrix into which cancellous bone may grow to provide fixation of the dowel to the patient’s bone ([0088]).
Visotsky as modified by Neal fails to disclose the dowel is configured as a mosaic structure. Boyer also discloses a dowel (60) for bone tissue (FIG 1F). Boyer teaches the dowel is configured as a mosaic structure ([0083], [0086], where being formed from multiple pieces is understood as being a mosaic structure). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Visotsky in view of Neal to provide the dowel as a mosaic structure, as taught by Boyer, in order to provide a structure suitable for the desired application ([0083], [0086]).
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Visotsky as applied to claim 1 above, and further in view of Jie (20170354501).
Regarding claim 11, Visotsky discloses the dowel fusion system of Claim 1, but fails to disclose further comprising plural dowels.
Jie also discloses a dowel fusion system for bone tissue comprising a dowel ([0087]). Jie teaches the dowel fusion system further comprising plural dowels ([0089]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Visotsky to include further comprising plural dowels, as taught by Jie, in order to provide multiple dowels for use as needed ([0089]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RENEE FLORENCIA NERENBERG whose telephone number is (571)272-9599. The examiner can normally be reached M-F 7:30-5.
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/R.F.N./Patent Examiner, Art Unit 3774
/MELANIE R TYSON/Supervisory Patent Examiner, Art Unit 3774