DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submissions filed on December 24, 2025 (arguments) and June 16, 2026 (claims) have been entered.
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 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.
The factual inquiries for establishing a background for determining obviousness under pre-AIA 35 U.S.C. 103(a) 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.
Claims 9, 11, 13, and 14 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Whipple (US 2006/0217717 A1) in view of Metcalf et al. (US 2012/0253398 A1), Reiley et al. (US 2011/0087296 A1), and Bono et al. (US 6,129,730 A).
Claim 9. Whipple discloses a system for fusing or stabilizing a plurality of bones, the system comprising:
an implant structure having a stem portion (stabilizer 10) and a head portion (bone screw 52), the head portion including a shank (shaft 54) that has a length such that it extends through the stem portion and distally from the stem portion, the implant structure having a linear longitudinal axis extending along the stem portion and the head portion,
the shank having a distal region with a first type of external threads (threads 56) that are shaped to interface with corresponding internal threads (threads 22) on the stem portion,
the stem portion having a length such that it can be stably implanted into a bone,
a tulip or a saddle structure (receiver member 60) attached to the head portion, a proximal end (at head 53) of the head portion spaced from a distal end (end of shaft 54 opposite end secured to head 53) of the shank at a distance such that the tulip or saddle structure is secured to the proximal end of the head portion when the distal end of the shank is implanted in the bone, and
a rod (rod 80) secured within the tulip or the saddle structure (Figs. 1-4; paras. 0015-0023).
Claim 11. Whipple discloses wherein the head portion is connected to the stem portion with a screw attachment (threads 56 of shaft 54 and threads 22 of stabilizer 10) along a length of the shank having the first type of external threads (Figs. 1-4; paras. 0015-0023).
Claim 13. Whipple discloses wherein the tulip or saddle structure comprises a first slot (groove 68) and a cavity (cavity that receives head 53 of bone screw 52 as shown in Fig. 4) for receiving the head portion (Figs. 1-4; paras. 0015-0023).
Claim 14. Whipple discloses wherein the tulip or saddle structure is rotatable through a range of motion (see para. 0022, which states that bone screw 52 and receiver member 60 have a polyaxial relationship) (Figs. 1-4; paras. 0015-0023).
Whipple fails to disclose wherein the distal region of the shank has a second type of external threads, wherein the second type of external threads extends along at least a length of the shank distal to the stem portion (claim 9), wherein the stem portion has a length such that it can be implanted across a sacroiliac joint, wherein a proximal portion of the stem portion is positionable in a sacrum and a distal end is positionable into an ilium (claim 9), wherein the range of motion is 60 degrees (claim 14), wherein the second type of external threads are deeper than the first type of external threads, thereby allowing the second type of external threads to better engage cancellous bone (claim 29).
However, Whipple states that the purpose of the stem portion (stabilizer 10) is to stabilize the head portion (bone screw 52) relative to bone and distribute forces on the bone anchor to the bone (see para. 0015).
Metcalf teaches the use of a system comprising: an implant structure (anchor element 20 and ball 34); a tulip or saddle structure (collar 33); and a rod (rod R); wherein the system is used in a sacroiliac stabilization procedure (see para. 0020) (Fig. 5; para. 0020).
Reiley teaches the use of a system comprising: an implant structure having a stem portion (implant structure 20) and a head portion (body 12, screw 14, nut 16, and washer 18), the head portion including a shank (body 12) that has a length such that it extends through the stem portion and distally from the stem portion; wherein the stem portion has a length such that it can be implanted across a sacroiliac joint (joint; see para. 0030), wherein a proximal portion (portion adjacent washer 18 as shown in Fig. 1) of the stem portion is positionable in a sacrum (bone segment 1; see para. 0030) and a distal end (end adjacent threads 30 as shown in Fig. 1) is positionable into an ilium (bone segment 2; see para. 0030); wherein the stem portion is configured to stabilize the sacroiliac joint (see paras. 0009 and 0046) (Figs. 1 and 2; paras. 0009, 0030, and 0046).
Bono teaches that a shank (screw 10) has a first type of external threads (threaded section 28) that are shaped to interface with corresponding internal threads (threads 54) on a bone engagement structure (plate 50) and a second type of external threads (threaded section 18) extending along at least a length of the shank distal to the bone engagement structure, wherein the second type of external threads are deeper than the first type of external threads, thereby allowing the second type of external threads to better engage cancellous bone, and thereby reducing the risk of pullout of the shank from the bone (see col. 3, ll. 47-60) (Figs. 1-5; col. 2, line 27 through col. 5, line 4).
It would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the system of Whipple such that the stem portion has a length such that it can be implanted across a sacroiliac joint, wherein a proximal portion of the stem portion is positionable in a sacrum and a distal end is positionable into an ilium (claim 9), as suggested by Reiley, as a system including a tulip or saddle structure may be used in a sacroiliac stabilization procedure as taught by Metcalf and the increased length of the stem portion would provide for stabilization of both bone segments across the joint. It would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the system of Whipple such that the distal region of the shank has a second type of external threads, wherein the second type of external threads extends along at least a length of the shank distal to the stem portion (claim 9) and the second type of external threads are deeper than the first type of external threads, thereby allowing the second type of external threads to better engage cancellous bone (claim 29), as suggested by Bono, in order to reduce the risk of pullout of the shank from the bone. It would have been obvious to one having ordinary skill in the art at the time the invention was made for the range of motion to be 60 degrees (claim 14), since it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art. In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980).
Response to Arguments
Applicant's arguments filed December 24, 2025 have been fully considered but they are not persuasive.
Applicant argues that it would not have been obvious to modify Whipple such that it would be implanted across a sacroiliac joint because Whipple teaches distributing forces over an increased area in bone, particularly a vertebra (see pg. 7). The Examiner disagrees. First of all, increasing the length of the anchor of Whipple would still provide for distribution of forces over an increased area in bone. Furthermore, Whipple does not necessitate that the anchor be used in the pedicle or other portion of a vertebra. In fact, in the entirety of the disclosure, including the claims, Whipple only uses the word “pedicle” twice and “vertebra” or “vertebrae” twelve times. However, Whipple uses the word “bone” 38 times (these do not include the use of the word “bone” in either “bone anchor” or “bone screw”), thus indicating that Whipple is not limited to just the pedicle or another portion of the vertebra. Furthermore, when describing the use of the anchor in the pedicle and the vertebra, Whipple uses the phrase “exemplary method” (see, for example, para. 0024), thereby indicating that such is merely an example and not limiting the use of the anchor to just the pedicle or another portion of the vertebra as alleged by Applicant.
In response to Applicant's argument that the Examiner's conclusion of obviousness is based upon improper hindsight reasoning (see pg. 7), it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971). In the instant case, it is clear that the rejection takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made and does not include knowledge gleaned only from the applicant's disclosure as (a) Whipple teaches a screw structure with a tulip that provides stability and distributes forces, (b) Metcalf teaches using a screw structure with a tulip in a sacroiliac stabilization procedure, and (c) Reiley teaches using a screw structure having a length such that a proximal portion can be implanted into a sacrum and a distal end can be implanted into an ilium as set forth in the rejection above.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JULIANNA N HARVEY whose telephone number is (571)270-3815. The examiner can normally be reached Mon.-Fri. 8:00am-5:00pm EST.
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/JULIANNA N HARVEY/Primary Examiner, Art Unit 3773
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