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.
Claims 11-20 are 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 11 at Lines 28-29 recites the limitation “and a second assembly configuration in which the elongated extension of the locking element extends into the cannulation of the bone anchor, the looped end of the flexible tension member is captured by the docking slot of the locking element, the open end of the flexible tension member is positioned distal of the distal end of the bone anchor, and the flexible body extends through the cannulation of the bone anchor, a bone tunnel formed in the fractured bone under repair, and the proximal and transverse openings of the locking element…” which positively recites the human body in combination with the system since the flexible body is recited as extending through a bone tunnel formed in the fractured bone. It is suggested that the limitations of Lines 28-29 be amended to clarify that the flexible body is configured to extend versus “extends”. Appropriate correction is required.
Claim 14 at Lines 3-4 recites the limitation “wherein the second assembly configuration further comprises the flexible body extending distally from the looped end through the cannulation of the first bone anchor, then diagonally to a proximal opening of the bone tunnel, then distally through the bone tunnel, then…” which positively recites the human body in combination with the system since the flexible body is recited as extending diagonally to a proximal opening of the bone tunnel then distally through the bone tunnel. It is suggested that the limitations of Lines 3-4 be amended to clarify that the flexible body is configured to extend versus “extends”. Appropriate correction is 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.
Claims 1-20 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 at Line 10 recites the limitation “the elongated shaft”. There is insufficient antecedent basis for this limitation in the claim. For purposes of examination, the limitation is being interpreted as “the elongated shank”. Appropriate correction is required.
Claim 2 recites “wherein the proximal head of the locking element is configured to nest within the anchor head.” which renders the claim indefinite as it is unclear which anchor head is being referred to since Claim 1 previously recites first and second bone anchors which each comprise an anchor head. For purposes of examination, the claim is being interpreted as “wherein the proximal head of the locking element is configured to nest within the anchor head of the first bone anchor”. Appropriate correction is required.
Claim 11 at Line 9 recites the limitation “the elongated shaft”. There is insufficient antecedent basis for this limitation in the claim. For purposes of examination, the limitation is being interpreted as “the elongated shank”. Appropriate correction is required.
Claim Objections
Claim 1 is objected to because of the following informalities and should be amended as follows:
“1. A bone fracture repair system, comprising: a flexible tension member having first and second free ends and a flexible body extending between the first and second free ends, the flexible tension member oriented in an assembly configuration wherein the flexible body comprises a U-shaped portion defining a looped end and an open end [[comprising]] defined by the first and second free ends wherein in a first assembly configuration, wherein in a second assembly configuration, and
wherein the open end of the flexible tension member is configured to be pulled taut in the distal direction, thereby creating tension in the flexible tension member which causes the locking element to translate distally relative to the first bone anchor and transition the bone fracture repair system from an unlocked state that permits movement of the flexible tension member to a locked state that prohibits movement of the flexible tension member, where the locked state is maintained via compression and friction applied to the flexible tension member between the mating surface of the first bone anchor and the engagement surface of the locking element.”
Appropriate correction is required.
Claim 4 is objected to because of the following informalities and should be amended as follows:
“4. The bone fracture repair system of claim 1, wherein in the second assembly configuration, extends distally from the looped end through the cannulation of the first bone anchor, then diagonally to the proximal end of the second bone anchor, then distally through the cannulation of the second bone anchor, then diagonally to the proximal head of the locking element, and then distally through the proximal opening of the locking element, the transverse openings of the locking element, and the cannulation of the first bone anchor.”
Appropriate correction is required.
Claim 5 is objected to because of the following informalities and should be amended as follows:
“5. The bone fracture repair system of claim 1, wherein each shank of the first and second bone anchors [[have]] has an outer surfacean outer surface comprising a non-threaded portion.”
Appropriate correction is required.
Claim 7 is objected to because of the following informalities: In Line 1, the word --the-- should be added before the word “docking”. Appropriate correction is required.
Claim 11 is objected to because of the following informalities and should be amended as follows:
“11. A bone fracture repair system, comprising: a flexible tension member having first and second free ends and a flexible body extending between the first and second free ends, the flexible tension member oriented in an assembly configuration wherein the flexible body comprises a U-shaped portion defining a looped end and an open end [[comprising]] defined by the first and second free ends of the flexible tension member; a bone anchor configured for implantation into bone, the bone anchor having an anchor head at a proximal end, an elongated shank extending between the anchor head and a distal end, and a cannulation extending longitudinally through the elongated shaft and having a proximal opening at the proximal end and a distal opening at the distal end, the anchor head comprising a proximal recess including a circumferential mating surface positioned within the proximal recess; a locking element having a proximal head and an elongated extension extending distally from the proximal head, the proximal head including a proximal opening, a pair of transverse openings, and a distal engagement surface, the elongated extension including a docking slot formed therein and configured to capture the looped end of the flexible tension member; wherein in a first assembly configuration, wherein in a second assembly configuration, and wherein the open end of the flexible tension member is configured to be pulled taut in the distal direction, thereby creating tension in the flexible tension member which causes the locking element to translate distally relative to the bone anchor and transition the bone fracture repair system from an unlocked state that permits movement of the flexible tension member to a locked state that prohibits movement of the flexible tension member, where the locked state is maintained via compression and friction applied to the flexible tension member between the mating surface of the bone anchor and the engagement surface of the locking element.”
Appropriate correction is required.
Claim 14 is objected to because of the following informalities and should be amended as follows:
“14. The bone fracture repair system of claim 11, wherein in the second assembly configuration, extends distally from the looped end through the cannulation of the first bone anchor, then diagonally to a proximal opening of the bone tunnel, then distally through the bone tunnel, then diagonally to the proximal head of the locking element, and then distally through the proximal opening of the locking element, the transverse openings of the locking element, and the cannulation of the bone anchor.”
Appropriate correction is required.
Claim 7 is objected to because of the following informalities: In Line 1, the word --the-- should be added before the word “docking”. Appropriate correction is required.
Allowable Subject Matter
Claims 1-20 would be allowable if rewritten or amended to properly overcome the rejection(s) under 35 U.S.C. 101 and 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action.
The following is a statement of reasons for the indication of allowable subject matter: Claims 1-20 of the instant application have not been rejected using prior art because none of the references or reasonable combinations thereof could be found which disclose or suggest all of the features of the claims, particularly a bone fracture repair system comprising the first and second bone anchors as recited, in addition to a flexible tension member comprising first and second free ends and being oriented in an assembly configuration having a looped end comprising a U-shaped portion and an open end comprising the first and second free ends, and a locking element with a proximal head including a pair of transverse openings, wherein in a first assembly configuration, the looped end of the flexible tension member is positioned proximal of the locking element, the open end of the flexible tension member is positioned distal of the distal end of the first bone anchor, and the flexible body extends through the proximal opening of the locking element, the transverse openings of the locking element, and the cannulation of the first bone anchor, and in a second assembly configuration, the elongated extension of the locking element extends into the cannulation of the first bone anchor, the looped end of the flexible tension member is captured by the docking slot of the locking element, the open end of the flexible tension member is positioned distal of the distal end of the first bone anchor, and the flexible body extends through the cannulation of the first bone anchor, the cannulation of the second bone anchor, and the proximal and transverse openings of the locking element before passing between the circumferential mating surface of the first bone anchor and the distal engagement surface of the locking element, and there is no reasonable motivation to modify the art of record to have these features.
The closest prior art of record appears to be: Jenkins Jr. (US Patent No. 5,571,139) and Goble (US Patent No. 7,172,595).
Jenkins Jr. discloses bidirectional cannulated suture anchors used in a patella fracture, wherein a first and second cannulated suture anchor are inserted through the patella across a fracture site and sutures extend through each suture anchor from both ends of the respective anchor, but Jenkins Jr. fails to disclose a locking element as claimed and a flexible tension member oriented in an assembly configuration as recited and the and second first assembly configurations as recited. Furthermore, there is no reason to modify Jenkins Jr. as claimed without destroying the invention.
Goble discloses bone fixation systems used in a knee joint, comprising a flexible tension member, a cannulated bone anchor, a cannulated locking element configured to threadably engage internal threads within the bone anchor, wherein the flexible tension member is inserted through both the cannulated bone anchor and the cannulated locking element such that the cannulated locking element clamps the tension member to the locking element and hence to the cannulated bone anchor, but Goble fails to disclose the flexible tension member oriented in an assembly configuration as recited, and the and second first assembly configurations as recited. Furthermore, there is no reason to modify Goble as claimed without destroying the invention.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
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 JESSICA WEISS whose telephone number is (571) 270-5597. The examiner can normally be reached Monday through Friday, 8:00 am to 4:00 pm EST. If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, KEVIN T. TRUONG, at 571-272-4705. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/JESSICA WEISS/Primary Examiner, Art Unit 3775
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