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.
Response to Arguments
Applicant's arguments filed 7/20/26 have been fully considered but they are not persuasive.
Applicant argues that prior art Vistosky does not teach or suggest that the device is capable of functioning as an arthrodesis dowel. The examiner respectfully disagrees, but the argument is moot as the amendments overcame the previous 102 rejection.
Applicant argues that prior art Neal does not teach or suggest that the device is capable of functioning as an arthrodesis dowel. The examiner respectfully disagrees. Using the broadest reasonable interpretation, the term “dowel” is an abutting piece used to prevent motion or slipping and does not require a specific shape. A functional limitation can be found obvious if the prior art is capable of performing the same function, regardless of whether or not it is explicit in the reference. In this case, Neal discloses a device that is implanted between two separate bones to fuse them together and therefore prevent motion or slipping (abstract). For clarification, the rejection below is based on the embodiment in FIG 5B, which has a structure that allows for it to be used as a dowel in an intercuneiform joint, even if the prior art does not directly disclose its use in an intercuneiform joint. With regards to Applicant’s argument on page 14 that it would not be obvious to modify Neal to include a retention member, the primary reference (Neal) is not required to state a need to a retention member, as the motivation is found in the secondary reference.
Applicant argues that prior art Hartdegen secures a spacer, not a dowel, and that prior art Neal gives no suggestion and has no need for external fixation. The examiner respectfully disagrees. With reference to the same interpretation of “dowel” as above, Hartdegen’s spacer functions as a dowel, as it does fit in an abutting piece to prevent motion or slipping. While Neal’s device is configured to fuse the bones together, external fixation helps ensure that it remains properly in place, without rotation.
Claim Objections
Claim 20 is a duplicate of claim 11. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 13-20 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Paragraphs [00156]-[00157] of the specification disclose the embodiment of FIG 11 with a dowel 100 and a transverse bore 108 as a separate and distinct embodiment of FIG 12 with a dowel 110 and a recessed channel 118. No mention is made of the ability to combine these two embodiments. The originally filed specification appears to lack sufficient support for the claimed combination of a retention member in a recess of Figure 12 with a suture anchor in a transverse bore of Figure 11.
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 13-20 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. Due to the lack of sufficient support for the combination of claimed components described above in the 112(a) rejection, the scope of the claims is unclear.
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) 1-2, 5-7, 9, and 12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hartdegen (20180353172).
Regarding claim 1, Hartdegen discloses a dowel fusion system, comprising a frustoconical dowel (150; FIG 3A; where tip 162 is frustoconical in shape, and the term “frustoconical” does not require the device to have that shape along the entire length) made of a biocompatible material ([0222]) a retention member (200, FIG 2A), the frustoconical dowel being configured to be placed within a tapered bore between longitudinally adjacent resected bones and allow for fixation of the longitudinally adjacent resected bones (FIG 5C), and the retention member engaging with or abutting a proximal surface of the frustoconical dowel (FIG 5C, [0103], “The plug head 160 may include a slot or channel 164 shaped to complementarily receive the clip bridge 206”) and attaching at opposing ends of the retention member to opposing bone surfaces (FIG 5C).
Regarding claim 2, Hartdegen discloses the dowel fusion system of Claim 1, wherein the biocompatible material is a metal ([0222]). Note that the prior art does not need to disclose the limitation “autograft, allograft, synthetic bone graft substitute, 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 terms “selected from” and “and/or”).
Regarding claim 5, Hartdegen discloses the dowel fusion system of Claim 1, wherein the frustoconical dowel further comprises a recess formed in a proximal surface of the frustoconical dowel and extending diametrically across the proximal surface (164).
Regarding claim 6, Hartdegen discloses the dowel fusion system of Claim 5, wherein the retention member sits in the recess in the proximal surface of the frustoconical dowel (FIG 5C, [0103]).
Regarding claim 7, Hartdegen discloses the dowel fusion system of Claim 1, wherein the retention member further comprises a staple (200; see Fig. 2A).
Regarding claim 9, 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 (200 sits in the in the recess 164 in the proximal surface of the dowel) and configured to engage the longitudinally adjacent resected bones ([0100]).
Regarding claim 12, Hartdegen 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 Hartdegen discloses the structure of the dowel as claimed, it is capable of being implanted into an intercuneiform joint as claimed).
Claim(s) 1, 3, and 4 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Chandran (6579293).
Regarding claim 1, Chandran discloses a dowel fusion system, comprising a frustoconical dowel (110; FIG 3; where tip 112 is frustoconical in shape, and the term “frustoconical” does not require the device to have that shape along the entire length) made of a biocompatible material (col 8 line 12) and a retention member (132), the frustoconical dowel being configured to be placed within a tapered bore between longitudinally adjacent resected bones and allow for fixation of the longitudinally adjacent resected bones (FIG 2), and the retention member engaging with or abutting a proximal surface of the frustoconical dowel (FIG 3, the top part of bore 119 can be interpreted as a proximal surface of the dowel) and attaching at opposing ends of the retention member to opposing bone surfaces (FIG 2).
Regarding claim 3, Chandran discloses the dowel fusion system of Claim 1, wherein the frustoconical dowel (110) further comprises a transverse bore (119) passing laterally through the frustoconical dowel (col 6 line 20).
Regarding claim 4, Chandran discloses the dowel fusion system of Claim 3, further comprising a tissue anchor (130) passing into and through the transverse bore ([col 6, line 20]).
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) 13-16 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Chandran (6579293 in view of Hartdegen (20180353172).
Regarding claim 13, Chandran discloses a mid-foot dowel fusion system, comprising a frustoconical dowel (110; FIG 3; where tip 112 is frustoconical in shape, and the term “frustoconical” does not require the device to have that shape along the entire length) made of a biocompatible material (col 8 line 12), the frustoconical dowel is configured to be placed within a tapered bore between longitudinally adjacent mid-foot bones and allow for fixation of the longitudinally adjacent resected bones (FIG 2), but fails to disclose a retention member, the retention member engaging with or abutting a proximal surface of the frustoconical dowel and attaching at opposing ends of the retention member to opposing bone surfaces, and the frustoconical dowel being having a transverse bore passing laterally therethrough, with a tissue anchor passing into and through the transverse bore.
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 further teaches a retention member (200, FIG 2A), the retention member engaging with or abutting a proximal surface of the frustoconical dowel (FIG 5C, [0103], “The plug head 160 may include a slot or channel 164 shaped to complementarily receive the clip bridge 206”) and attaching at opposing ends of the retention member to opposing bone surfaces (FIG 5C). 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 Chandran’s dowel system to include a retention member engaging with or abutting a proximal surface of the frustoconical dowel and attaching at opposing ends of the retention member to opposing bone , as taught by Hartdegen, in order to further enhance the prevention of rotation of the dowel once inserted and corresponding bone portions to which it is attached ([00107]).
With regards to claim 14, Chandran discloses the dowel fusion system of Claim 13, but fails to disclose wherein the biocompatible material is selected from the group of nickel-titanium based alloys, stainless steel, cobalt-based alloys, and titanium.
Hartdegen further teaches that the biocompatible material is stainless steel ([0222]). Note that the prior art does not need to disclose the limitation “nickel-titanium based alloys, cobalt-based alloys, and titanium” to meet the claimed invention since the claim recites the limitations in the alternative only using the terms “selected from” and “and/or”). 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 Chandran’s dowel system to include that the biocompatible material is stainless steel, as taught by Hartdegen, 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 design choice. In re Leshin, 125 USPQ 46.
With regards to claim 15, Chandran as modified by Hartdegen discloses the dowel fusion system of Claim 13, 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 164) and the retention member engages with the recess (Hartdegen FIG 5C, [0103]).
With regards to claim 16, Chandran as modified by Hartdegen discloses the dowel fusion system of Claim 13, wherein the retention member further comprises a staple (Hartdegen 200; see Fig. 2A).
With regards to claim 18, Chandran as modified by Hartdegen discloses the dowel fusion system of Claim 13, wherein 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 rejected under 35 U.S.C. 103 as being unpatentable over Hartdegen as applied to claim 6 above, and further in view of Shepard (20040078078).
Regarding claim 8, Hartdegen discloses the dowel fusion system of Claim 6, and further that the retention member (200) comprises a plate (206), but 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 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 rejected under 35 U.S.C. 103 as being unpatentable over Hartdegen (20180353172) in view of Neal (20160128701), and further in view of Boyer (20010039457).
Regarding claim 10, Hartdegen 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 discloses a dowel fusion system, comprising a frustoconical dowel (200””; FIG 5G) made of a biocompatible material ([0086-0087]). Neal teaches that the biocompatible material is porous ([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 further modified Hartdegen’s dowel system to include that the biocompatible material is porous, as taught by Neal, 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 design choice, and Hartdegen discloses the use of “any material providing the elastic properties” ([0222]). In re Leshin, 125 USPQ 46.
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 Hartdegen 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 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Hartdegen in view of Jie (20170354501).
Regarding claim 11 and 20, Hartdegen 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 Hartdegen to include further comprising plural dowels, as taught by Jie, in order to provide multiple dowels for use as needed ([0089]).
Claim(s) 17 is rejected under 35 U.S.C. 103 as being unpatentable over Chandran in view of Hartdegen, as applied to claim 13 above, and further in view of Shepard (20040078078).
With regards to claim 17, Chandran as modified by Hartdegen discloses the dowel fusion system of Claim 13, wherein the retention member (200) comprises a plate (206), but fails to disclose the tissue anchor having 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) 19 is rejected under 35 U.S.C. 103 as being unpatentable over Hartdegen (20180353172) in view of Neal (20160128701).
Regarding claim 19, Hartdegen discloses the dowel fusion system of Claim 1, but fails to disclose wherein the biocompatible material is porous.
Neal discloses a dowel fusion system, comprising a frustoconical dowel (200””; FIG 5G) made of a biocompatible material ([0086-0087]). Neal teaches that the biocompatible material is porous ([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 further modified Hartdegen’s dowel system to include that the biocompatible material is porous, as taught by Neal, 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 design choice, and Hartdegen discloses the use of “any material providing the elastic properties” ([0222]). In re Leshin, 125 USPQ 46.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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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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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/R.F.N./Patent Examiner, Art Unit 3774
/SARAH W ALEMAN/Primary Examiner, Art Unit 3774
