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 § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claim 2 is rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101). Claim 2 requires the elongate members to create an interlocked interface between the ilium bone structure and the sacrum bone structure. This limitation requires part of a human and is therefore non-statutory.
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.
Claims 1 and 2 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.
Claim 1 recites the limitation "Said proximal connection point” in line 17. There is insufficient antecedent basis for this limitation in the claim.
Claim 1 recites the limitation "said distal connection point" in line 17. There is insufficient antecedent basis for this limitation in the claim.
Claim 1 recites “a plurality of elongate member midpoints” in line 18. However, it is unclear whether this limitation refers to midpoints on the elongated member or on the deflectable elongate members. Please clarify.
Claim 1 recites the limitation "said fixed connections" in 26. There is insufficient antecedent basis for this limitation in the claim.
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.
Claim(s) 1 and 2 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Chirico et al. (Pub. No. US 2009/0292323 A1).
Regarding claims 1 and 2, Chirico et al. discloses a system 501/512 (figures 22C-22E) for stabilizing a dysfunctional sacroiliac (SI) joint (this is an intended use recitation. The device is capable of stabilizing a dysfunctional SI joint if one so desires), said dysfunctional SIjoint comprising an ilium bone structure and sacrum bone structure, said system comprising: an expandable prosthesis 501 (figures 22C-22D), said expandable prosthesis comprising an elongated member 501 adapted to be inserted into an SI junction in said dysfunctional SI joint, said SI junction defined between said ilium bone structure and said sacrum bone structure of said SI joint, said elongated member comprising a proximal end region, a distal end region disposed opposite said proximal end region and a longitudinal axis (figure 22E), said elongated member further comprising an expandable mid-region (figure 22E) extending from said proximal end region to said distal end region, said expandable mid-region comprising a plurality of independent deflectable elongate members (figures 22E), each of said plurality of deflectable elongate members solely connected and, thereby, fixed to said proximal end region and said distal end region of said elongated member (figure 22E), each of said plurality of deflectable elongate members further comprising a midpoint between said proximal connection point and said distal connection point, whereby said expandable prosthesis further comprises a plurality of elongate member midpoints, each of said plurality of deflectable elongate members configured and adapted to separately and independently transition from a compressed configuration (figure 22C), when said expandable mid-region is in a compressed position, to a deflected configuration, when said expandable mid- region is in a non-compressed position (figure 22E), whereby said plurality of deflectable elongate members deflects outwardly from said proximal end region and said distal end region of said elongated member in relation to said longitudinal axis of said elongated member and forms an inverted V- shaped configuration (figure 22E), wherein said plurality of deflectable elongate members comprises a maximum outward deflection at said plurality of midpoints in relation to said fixed connections of said plurality of deflectable elongate members to said proximal end region and said distal end region of said elongated member (figure 22E); and a prosthesis deployment assembly 512 and “push rod” (paragraph 0136) adapted to releasably engage and deliver said expandable prosthesis into said SI junction in said dysfunctional SI joint, said prosthesis deployment assembly comprising an alignment member 512 and a delivery handle “push rod”, said alignment member comprising an internal lumen sized and configured to receive said expandable prosthesis therein (paragraph 0136), wherein said expandable mid-region of said expandable prosthesis is in said compressed position (paragraph 0136), said delivery handle “push rod” comprising a proximal end and a distal end disposed opposite said proximal end, said distal end of said handle comprising an elongated rod section sized and configured to be received in and slidably transition from a retracted position to an extended position within said internal lumen of said alignment member (paragraph 0136-0137), whereby, when said elongated rod section of said delivery handle is in said retracted position and said expandable member is disposed in said internal lumen of said alignment member, and said elongated rod section of said delivery handle said transitions from said retracted position to said extended position within said internal lumen of said alignment member, said expandable prosthesis is discharged out of said internal lumen of said alignment member (figures 22C-22E; paragraphs 0136-0137), wherein said plurality of deflectable elongate members of said expandable prosthesis said transitions to said deflected configuration (figure 22E; paragraphs 0136-0137). When said expandable prosthesis 501 is said discharged out of said internal lumen of said alignment member and said inserted into said SI junction of said dysfunctional SI joint and said plurality of deflectable elongate members of said expandable prosthesis are in said deflected configuration, said plurality of deflectable elongate members creates an interlocked interface between said ilium bone structure and said sacrum bone structure (this is an intended use recitation. The device is capable of being used it the SI joint and would create an interlocked interface therein, so it meets the claimed limitations).
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Response to Arguments
Applicant’s arguments with respect to claim(s) 1 and 2 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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 Lynnsy Summitt whose telephone number is (571)270-78567856. The examiner can normally be reached on Monday through Thursday from 8am until 5pm.
If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, Eduardo Robert, 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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/LYNNSY M SUMMITT/Primary Examiner, Art Unit 3773