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
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.
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.
Claims 1-3 and 5 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Donner (US 2012/0296428 A1).
Regarding claim 1, Donner discloses a method for fusing a sacroiliac joint (Figs. 102B, 108A; para. 0003) having a sacrum 1004, an ilium 1005, a joint plane 1030, a posterior inferior aspect 2006 (Fig. 108A; para. 0291), an intra-articular region 1044 (Fig. 106B), and a sacroiliac joint space 3000 (Fig. 106B; para. 0313) defined between the sacrum and the ilium, the method comprising:
a. positioning an implant 25 (Fig. 123A; paras. 0360-0361) up to the posterior inferior aspect of the sacroiliac joint (cf., e.g., Figs. 108A; para. 0302, describing access at the sacroiliac joint near inferior end 2022 of the posterior inferior access region 2016 of the sacroiliac joint articular region 1044 via the sacroiliac joint line 2019), the implant 25 having an implant longitudinal axis (see annotated Fig. 123A, below), an implant length (id.), a distal end 42, a proximal end 43, a pair of longitudinally extending finger members (wings) 6516 (annotated Fig. 123A, below; paras. 0360-0361) extending the length (id.) and including a sacral member (id.) and an iliac member (id.) spaced apart from one another by a connecting portion (id.) integrally coupled therebetween at the base of the implant (and with member 50 integrally extending from the connecting portion; id.), the iliac and sacral members extending further distally than the connecting portion (id.) and defining an opening 6512 bound by the pair of longitudinally extending finger members 6516 and the connecting portion (id.) (with member 50 extending into the opening 6512);
b. aligning the implant 25 such that the implant longitudinal axis is generally in line with the joint plane (supra); and
c. delivering the implant 25 at the sacroiliac joint such that:
the iliac member enters the ilium lateral to the sacroiliac joint space (para. 0361);
the sacral member enters the sacrum medial to the sacroiliac joint space (para. 0361); and
the opening extends across the sacroiliac joint space (Fig. 123A and para. 0361). It is noted that because the sacral member (one of the wings; id.) is delivered to the sacrum and the iliac member (the other wing; id.) is delivered to the ilium, the connecting portion (annotated Fig. 123A, below) and the opening 6512 extend across the sacroiliac joint space (with member 50 extending from the connecting portion into the opening 6512). It is further noted that the claim defines the opening as being bound by the pair of longitudinally extending finger members 6516 and the connecting portion (base), and does not require the opening to be unobstructed.
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Regarding claim 2, the opening comprises a width W (annotated Fig. 123A, above) extending between the pair of longitudinally extending finger members 6516 which is wider than a width w of a portion of the sacroiliac joint space 3000 (Fig. 106B; para. 0291) at the intra-articular region 1044 (Fig. 106B) of the sacroiliac joint (the joint is separate by member 50 that has width w)
Regarding claim 3, an implant 25 configuration and size is selected where the opening 6512 comprises a width W (annotated Fig. 123A, above) extending between the pair of longitudinally extending finger members 6516 which is wider than a width w (id.) of a portion of the sacroiliac joint space 3000 (Fig. 106B; para. 0291) at the intra-articular region 1044 (Fig. 106B) of the sacroiliac joint where the implant 25 is delivered (the joint is separated by member 50 that has width w).
Regarding claim 5, the connecting portion (annotated Fig. 123A, above) comprises a planar member (see annotated Fig. 123E, below) having opposing planar surfaces and a distance between the opposing planar surfaces defining a connecting portion thickness t.
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Claim Rejections - 35 USC § 103
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.
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.
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 4 is rejected under 35 U.S.C. 103 as being unpatentable over Donner (US 2012/0296428 A1).
Donner discloses the claimed invention including wherein the iliac and sacral members (i.e., the elongated finger members 6516; annotated Fig. 123A, above) extend further distally than the connecting portion (id.). However, the length is not explicitly recited to be approximately 5 mm.
However, it would have been obvious to a person having ordinary skill in the art before the effective filing date to configure the iliac and sacral members to extend a desired length, including approximately 5 mm, e.g., to gain purchase with viable bone of a particular patient.
Double Patenting
Claims 1-3 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3 of U.S. Patent No. 12,150,733. Although the claims at issue are not identical, they are not patentably distinct from each other because the substantive difference between the application claims and the patent claims is that the patent claims include more elements and are more specific. Specifically, patent claim 1 additionally recites positioning an access sleeve and particulars thereof including delivering first and second pins, and coupling an inserter to the implant. However, apart from these additional limitations, application claims 1-3 recite the same subject matter as patent claims 1-3.
Regarding application claim 1, patent claim 1 recites a method for fusing a sacroiliac joint having a sacrum, an ilium, a joint plane, a posterior inferior aspect, an intra-articular region, and a sacroiliac joint space defined between the sacrum and the ilium, the method comprising:
positioning an implant up to the posterior inferior aspect of the sacroiliac joint (this limitation is inherent in “positioning an access sleeve up to the posterior inferior aspect of the sacroiliac joint” at the beginning of patent claim 1, clause a., together with “delivering the implant at the sacroiliac joint” at claim 1, clause f.), the implant having an implant longitudinal axis, an implant length, a distal end, a proximal end, a pair of longitudinally extending finger members extending the length and including a sacral member and an iliac member spaced apart from one another by a connecting portion coupled therebetween, the iliac and sacral members extending further distally than the connecting portion and defining an opening bound by the pair of longitudinally extending finger members and the connecting portion (patent claim 1, clause e.);
aligning the implant such that the implant longitudinal axis is generally in line with the joint plane (this limitation is inherent in “aligning the access sleeve to the sacroiliac joint such that the longitudinal axis is generally in line with the joint plane” at patent claim 1, clause b., together with “delivering the implant at the sacroiliac joint” at patent claim 1, clause f.); and
delivering the implant at the sacroiliac joint such that:
the iliac member enters the ilium lateral to the sacroiliac joint space;
the sacral member enters the sacrum medial to the sacroiliac joint space; and the opening extends across the sacroiliac joint space (patent claim 1, clause f.).
Application claims 2 and 3 are the same as patent claims 2 and 3, respectively.
Thus, the invention of the patent claims is in effect a “species” of the “generic” invention of the application claims. It has been held that the generic invention is “anticipated” by the “species”. See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993). Since the application claims are anticipated by the patent claims, they are not patentably distinct from the patent claims.
Allowable Subject Matter
Claims 6-8 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.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAVID C COMSTOCK whose telephone number is (571)272-4710. The examiner can normally be reached M-F 9:00-5:00 PST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Eduardo Robert can be reached at 571-272-4719. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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DAVID C. COMSTOCK
Examiner
Art Unit 3773
/DAVID C COMSTOCK/Examiner, Art Unit 3773
/JULIANNA N HARVEY/Primary Examiner, Art Unit 3773