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 .
Priority
This application claims priority from provisional application 61/606,221, filed 03/09/2012.
Status of Claims
Claims 1-7 are pending.
Claims 2, 3, and 5 have been withdrawn from consideration.
(The applicant must amend these claims to have their status marked as Withdrawn)
Claim 8 has been cancelled.
Election/Restrictions
Applicant elected Species 1 (Figures 1A-C on 05/29/2025 without traverse (MPEP § 818.03(a)).
Information Disclosure Statement
The Information Disclosure Statement filed on 11/04/2025 has been considered by the examiner.
The information disclosure statement has citations stricken through. The applicant has cited whole US applications instead of individual documents and references from prosecution of these applications. This is the equivalent to citing an author or the entire work of an author rather than an individual book.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because:
Figure 1B remains objected to because it is unclear what reference number 32 is actually pointing out. The applicant explained that Figure 1B is just showing the sheath 22, which is the larger outer portion in Figure 1A and that reference number 32 is pointing out the cannula which is the dashed line in Figure 1A. If this is the case then the opening of the sheath is missing from Figure 1B. As seen in Figure 1A there are openings at each end of the sheath. One opening around pin 26 and one opening around delivery rod 24 that are both shown as bigger than the cannula 32. Also Figure 1A shows outer wall portions 34 having different thicknesses and not being aligned, but Figure 1B shows them being symmetrical and uniform.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The objection to the disclosure for missing/outdated priority information has been withdrawn.
However the specification is remains objected to for the unclear recitation in lines 7-12. These lines state that this application “may be related to one or more” other listed applications. This priority needs to be clarified. Is the priority being claimed or not?
The specification is also objected to for unclear incorporation by reference terminology in paragraph [0002]. The specification states that all publications and applications mentioned are incorporated to the same extend as if they were “specifically and individually incorporated by reference”. The sentence does not clearly identify the documents to be incorporated by reference as required by 37 CFR 1.57(c). This general incorporation by reference statement can result in a failure by the public to recognize the incorporation by reference of the materials because the statement is separated from the materials (publications and patent applications) to be incorporated. The use of the term “mentioned” in this sentence is a “mere reference” and does not amount to incorporation by reference. See MPEP 608.01 (p)(1) and 37 CFR 1.57(h). Furthermore, the clause “to the same extent as if each individual publication or patent application was specifically and individually indicated to be incorporated” is an admission that the references mentioned in the specification were not specifically and individually identified to be incorporated by reference. The applicant cites the two required elements in their arguments on page 6, but the as explained above, the applicant’s recitation fails to meet requirement number 2. This recitation fails to “clearly identify” the documents.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The previous 112 rejection have been withdrawn in view of the applicant’s amendments.
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 1, 4, 6, and 7 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.
The claims have been amended to require the implant to be inserted into the joint without predrilling or broaching with separate tools, which renders them indefinite. The elected embodiment clearly discloses pin 26 and broaches 30 that are connected to the implant but are separate components. A person of ordinary skill in the art would not be able to determine the scope of this phrase because it is unclear what is meant by separate tools. Do they need to be wholly removed and not touching the implant? Does separate just mean separately identifiable? If the tool can be removed does that make it separate? The applicant is advised to further define the steps of inserting the implant to clarify that the hole is formed by a portion of the implant.
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 1, 4, 6, and 7 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Reiley et al (Reiley) US 2011/0087296 A1 in view of Schenk USPN 5,899,906.
(Note: the publication falls within 1 year of this application’s effective filing date, but it also includes an additional inventor not named in this application, therefore making it qualify as art under both 102(a) and (e).
1. Reiley discloses the invention substantially as claimed being a method for fusing bone (Figure 11), comprising:
delivering an implant 20 with a linear, non-rotational force through an ilium (Figure 11), transversely across a sacro-iliac joint, and into a sacrum such that the implant extends from the ilium, across the sacro-iliac joint, and into the sacrum [0010],
wherein the implant 20 includes an elongated body (Figures 4, 6, 7) having a longitudinal axis and an outer profile (Figures 4, 6, 7) in a cross-section transverse to the longitudinal axis, the outer profile having a configuration that is adapted to resist rotation once implanted (Triangular shape resists rotation Figures 4, 6, 7); and
a plurality of cutting edges extending distally from and integral with the elongate body (the claim does not define the edges as sharp or what they cut, the pointed edges of Figures 4, 6, 7, all qualify as cutting edges because they are capable of cutting softer materials, additionally Figure 7 discloses cutting edges 36).
Reiley discloses that his implant is inserted following drilling and broaching using separate tools shown in Figures 8C-D. The implant is sized such that it can be inserted into the hole that is the same size as the threaded anchor screw (Figure 8D shows the triangular cross-section is smaller than the opening and Figures 8E-F show the anchor 14 is the same size as the opening). Reiley goes on to say that the implant is inserted and serf screws beyond the opening previously made by at least 5 mm [0066] Figures 8E-F. However, Reiley does not disclose the implant is inserted into the joint without predrilling or broaching with separate tools.
Schenk teaches the use of self-drilling screw threads utilizing flutes 70 (5:21-23) is old and well known in the art of bone screws/anchors for the purpose of eliminating the step of predrilling.
It would have been obvious to one having ordinary skill in the art at the time the invention was made to combine the self-drilling threads/flutes of Schenk with the anchor 14 of the implant of Reiley in order to allow the surgeon to drill the entire insertion path of the implant using just the anchor and no separate tools.
4. Reiley discloses the outer profile of the elongate body has rectilinear configuration (triangular shape Figures 4, 6, 7).
6. Reiley discloses the method further comprising:
driving a guide pin 12 through the ilium (Figure 8H);
driving the guide pin transversely across the sacro-iliac joint (Figure 8H [0010]);
driving the guide pin into the sacrum (Figure 8H [0010]); and
where the delivering step comprises delivering the implant over the guide pin (Figure 8I [0010]).
7. Reiley discloses delivering a second implant through the ilium, transversely across the sacro-iliac joint, and into the sacrum (Figure 11 shows multiple implants inserted as claimed).
Response to Arguments
Applicant's arguments filed 11/07/2025 have been fully considered but they are not persuasive.
The objections and 112 rejections have been addressed above.
In regards to the prior art rejections the applicant argues that Reiley fails to disclose the implant is inserted without predrilling or broaching with separate tools. This is not persuasive because Reiley discloses the implant anchor is advanced beyond the predrilled opening (Figure 8F). Reiley further discloses even the triangular cross-section is sized to fit within an opening which is shown as the same size as the anchor 14 (Figures 8D-E). In view of this and the teachings of Schenk, it would have been obvious to one of ordinary skill in the art that the threads could be modified to be self-drilling allowing for insertion without the separate tools.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 CHRISTOPHER D PRONE whose telephone number is (571)272-6085. The examiner can normally be reached Monday-Friday 10 am - 6 pm (HST).
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melanie R 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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CHRISTOPHER D. PRONE
Primary Examiner
Art Unit 3774
/Christopher D. Prone/Primary Examiner, Art Unit 3774