DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Election/Restrictions
Applicant’s election without traverse of Group I (insertion device claims 1-11) and Species B (Fig. 13) in the reply filed on March 9, 2026 is acknowledged.
Claims 3-4 are being withdrawn from consideration as being drawn to alternate embodiments that were not elected. Claims 1-2 under a very broad interpretation seem to be capable of reading on the elected group/species. However, claims 3 and 4 do not seem to have support when relating to the elected species.
Claim 3 seems to be solely geared towards Fig. 12 element 56. Claim 4 seems to be solely geared towards Fig. 10 element 48.
Drawings
Figs. 13-15 seem to have lines that are not pointing to the correct parts. For instance, Fig. 13, reference 144 is almost pointing to the bottom edge of a shaft and in Fig. 15 it is pointing to the inner shaft rather than the outer shaft. In Fig. 15, 145 says it is the threaded features, but it is pointing to the inner shaft. Corrected drawings are 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 10 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 10, line 2 recites “the through-hole of the fusion implant” which lacks antecedent basis in the claims.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of pre-AIA 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 –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
(e) the invention was described in (1) an application for patent, published under section 122(b), by another filed in the United States before the invention by the applicant for patent or (2) a patent granted on an application for patent by another filed in the United States before the invention by the applicant for patent, except that an international application filed under the treaty defined in section 351(a) shall have the effects for purposes of this subsection of an application filed in the United States only if the international application designated the United States and was published under Article 21(2) of such treaty in the English language.
Claim(s) 1-2 and 6 is/are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Sasso et al. (US 2004/0225292; “Sasso”).
Claim 1, Sasso discloses an insertion device (Fig. 9) for implanting a fusion implant across a sacroiliac joint (Fig. 9), comprising: an inner shaft (352) having a proximal end (upper end) and a distal end (end that 342b points towards); an outer shaft (400) having a proximal end (upper end) and a distal end (where 404 points) and coupled to the inner shaft such that the inner shaft can rotate and travel along a longitudinal axis of the insertion device independently of the outer shaft (Fig. 9; paragraphs [0060]-[0062]), wherein the distal end comprises at least one counter-torque feature (405) for engaging a counter-torque feature of the fusion implant (Fig. 9); and a pusher (352) having a proximal end (upper end) and a distal end (end that end that 343b points towards), with the distal end including a head (Fig. 8; 351) capable of pushing fusion-promoting material into the fusion implant (Figs. 8 and 9).
Claim 2, Sasso discloses the insertion device of claim 1, wherein the distal end of the inner shaft comprises a coupling feature (Fig. 8; 351) configured to engage with a fusion implant (Figs 8-9; paragraph [0059]).
Claim 6, Sasso discloses the insertion device of claim 1, wherein the pusher includes a blunted feature (while the proximal end of the shaft 352 is not shown, it is apparent from reading the document in regards to 52, 152, 252, and 352, that this shaft is something the doctor would be pushing to the screw, much like a guide wire or guide rod, the end of such a shaft would not be sharp as it would become hazardous, so it will be relatively blunt so it does not poke and injure the doctor) along the proximal end of the pusher (Figs. 8 and 9; furthermore, the outer surface shown above the distal end could be considered the proximal end that is blunt, since it is a smooth surface rather than having spikes or barbs extending therefrom).
Claim(s) 1 and 8-10 is/are rejected under pre-AIA 35 U.S.C. 102(e) as being anticipated by Robinson (US 2013/0072984).
Claim 1, Robinsons discloses an insertion device (Fig. 17-22) capable of implanting a fusion implant across a sacroiliac joint (Figs. 17-22; abstract), comprising: an inner shaft (Fig. 22; 220) having a proximal end (upper end) and a distal end (end that 214 points towards); an outer shaft (210) having a proximal end (upper end) and a distal end (where 214 points) and coupled to the inner shaft such that the inner shaft can rotate and travel along a longitudinal axis of the insertion device independently of the outer shaft (Figs. 17-22; paragraphs [0050]-[0055]), wherein the distal end comprises at least one counter-torque feature (Fig. 22; 214) for engaging a counter-torque feature of the fusion implant (Fig. 22); and a pusher (paragraph [0055]; guidewire) having a proximal end (upper end not shown) and a distal end (bottom end not shown), with the distal end including a head (distal end of the guide wire) capable of pushing fusion-promoting material into the fusion implant (Fig. 22; push a large guide wire through 240 and it will push out material that is in the lumen).
Claim 8, Robinson discloses the insertion device of claim 1, wherein the proximal end of the inner shaft comprises a proximal enlarged portion (Fig. 21; where 220 points, and/or the threaded portion shown in Fig. 16 just below the hub) configured to mate with the proximal end of the outer shaft to prevent the inner shaft from continuing to travel along the longitudinal axis independent of the outer shaft (Fig. 21).
Claim 9, Robinson discloses the insertion device of claim 1, wherein the proximal end of the pusher comprises a proximal enlarged portion (Fig. 21; where 220 points and/or the threaded portion shown in Fig. 16 just below the hub) configured to limit travel of the head of the pusher relative to the fusion implant coupled to the insertion device (Fig. 21).
Claim 10, Robinson discloses the insertion device of claim 9, wherein the proximal enlarged portion of the pusher is configured to prevent the head of the pusher from traveling into a through-hole of the fusion implant (Fig. 21).
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim 5 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Sasso et al. (US 2004/0225292; “Sasso”), in view of Robinson (US 2013/0072984).
Claim 5, Sasso discloses the insertion device of claim 1, wherein in an alternate embodiment the inner shaft has a lumen (Figs 2, 6, and 7; 54, 154, and 254).
However, the there is not a third parts such as a guidewire/pusher involved
Robinson teaches an insertion device (Figs. 21-22), having an inner shaft (220), and outer shaft (210) and a pusher (paragraph [0062]; guide wire) wherein the inner shaft includes a lumen (224) that extends along the entire length of the inner shaft and which is sized and shaped to allow the head of the pusher to travel along the length of the lumen (paragraph [0062]).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to make the inner shaft of Sasso include a lumen (like the alternate embodiments of Sasso) and include a guidewire, as taught by Robinson, which can act as a pusher, in order to aid in positioning the insertion tool (paragraph [0062]).
Claims 7 and 11 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Sasso et al. (US 2004/0225292; “Sasso”).
Claim 7, Sasso discloses the insertion device of claim 1.
However, in the embodiment shown in Fig. 9, the pusher does not include a guide lumen.
In alternate embodiments, the pusher includes a guide lumen that extends along the length of the pusher (Figs. 2, 6, and 7; 54, 154, 254).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to swap out the pusher of Fig. 9 for any of the other ones, since it is the same device performing the same function of guiding other tools to the screw (paragraph [0060]) and the lumen would allow for material to be inserted therethrough (paragraph [0035]).
Claim 11, Sasso discloses the insertion device of claim 1.
However, in the embodiment shown in Fig. 9, the pusher does not include a guide lumen.
In alternate embodiments, the pusher includes a guide lumen (Figs. 2, 6, and 7; 54, 154, 254) configured to form a sliding fit oven an implantation tool (Figs. 2, 6, and 7; a guide wire could fit in the lumen).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to swap out the pusher of Fig. 9 for any of the other ones, since it is the same device performing the same function of guiding other tools to the screw (paragraph [0060]) and the lumen would allow for material to be inserted therethrough (paragraph [0035]).
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kevin Truong can be reached at (571)272-4705. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Zade Coley/Primary Examiner, Art Unit 3775
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