DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Specification
The abstract of the disclosure is objected to because it contains language that can be
inferred: “The present invention is generally directed to” (at line 1).
Applicant is reminded of the proper language and format for an abstract of the
disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a
separate sheet within the range of 50 to 150 words in length. The abstract should describe the
disclosure sufficiently to assist readers in deciding whether there is a need for consulting the
full patent text for details.
The language should be clear and concise and should not repeat information given in
the title. It should avoid using phrases which can be inferred, such as, “The disclosure
concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In
addition, the form and legal phraseology often used in patent claims, such as “means” and
“said,” should be avoided.
A corrected abstract of the disclosure is required and must be presented on a separate
sheet, apart from any other text. See MPEP § 608.01(b).
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, the term “preassembled” renders the claim unclear because the time or event relative to which the device is assembled is unclear. As best understood, and for purposes of examination, this limitation will be treated as reciting that the saddle, or clamp attached to the saddle, are either assembled or capable of being assembled as claimed.
Claim 2, line 3, “the fastener attached to the bone” renders the claim unclear because the fastener being attached to bone is previously established in the alternative and is not necessarily present. As best understood and for purposes of examination, this limitation will be treated as a statement of intended use.
Claim 3, line 5, “the interference bump” lacks antecedent basis.
Claim 3, line 6, “the fastener attached to the bone” renders the claim unclear because the fastener being attached to bone is previously established in the alternative and is not necessarily present. As best understood and for purposes of examination, this limitation will be treated as a statement of intended use.
Claim 4, line 5, “the fastener attached to the bone” renders the claim unclear because the fastener being attached to bone is previously established in the alternative and is not necessarily present. As best understood and for purposes of examination, this limitation will be treated as a statement of intended use.
Claim 4, line 6, “when the saddle pulled upwardly” lacks antecedent basis.
Claim 4, lines 6-7, “the locked fastener head attached to the bone”
Claim 4, lines 7-8, “the fastener head attached to the bone” renders the claim unclear because this condition has not been established and it appears the fastener head per se does not attach to bone.
Claim 10, line 2, “the bone fastener” lacks consistent antecedent basis.
Claim 11, the term “preassembled” renders the claim unclear because the time or event relative to which the device is assembled is unclear. As best understood, and for purposes of examination, this limitation will be treated as reciting that the saddle, or clamp attached to the saddle, are either assembled or capable of being assembled as claimed.
Claim 12, line 3, “the fastener attached to the bone” renders the claim unclear because the fastener being attached to bone is previously established in the alternative and is not necessarily present. As best understood and for purposes of examination, this limitation will be treated as a statement of intended use.
Claim 13, line 5, “the interference bump” lacks antecedent basis.
Claim 13, line 6, “the fastener attached to the bone” renders the claim unclear because the fastener being attached to bone is previously established in the alternative and is not necessarily present. As best understood and for purposes of examination, this limitation will be treated as a statement of intended use.
Claim 14, line 5, “the fastener attached to the bone” renders the claim unclear because the fastener being attached to bone is previously established in the alternative and is not necessarily present. As best understood and for purposes of examination, this limitation will be treated as a statement of intended use.
Claim 14, line 6, “when the saddle pulled upwardly” lacks antecedent basis.
Claim 14, lines 6-7, “the locked fastener head attached to the bone”
Claim 14, lines 7-8, “the fastener head attached to the bone” renders the claim unclear because this condition has not been established and it appears the fastener head per se does not attach to bone.
Claim 17 is unclear because it is understood from the specification (e.g., paras. 0085-0090 and Figs. 32-34) that the pair of protrusions are receivable in opposed openings in the clamp and not in the tulip. Moreover, it is unclear how the protrusions could be received in the tulip when they would need to pass through the clamp, and the protrusions engaging the tulip would prevent the vertical motion described between the clamp and the tulip (especially if the openings were sized to the protrusions such that they could restrict motion to uniplanar motion). As best understood, and for purposes of examination, claim 17 will be considered as reciting the pair of protrusions being receivable in opposed openings in the clamp.
Claim 19, line 2, “the tulip element” lacks antecedent basis.
Claim 19 is further unclear because it is understood from the specification (e.g., paras. 0085-0090 and Figs. 32-34) that the pair of protrusions are receivable in opposed openings in the clamp and not in the tulip. Moreover, it is unclear how the protrusions could be received in the tulip when they would need to pass through the clamp, and the protrusions engaging the tulip would prevent the vertical motion described between the clamp and the tulip (especially if the openings were sized to the protrusions such that they could restrict motion to uniplanar motion). As best understood, and for purposes of examination, claim 19 will be considered as reciting the pair of protrusions being receivable in opposed openings in the clamp.
Claim 20, line 2, “the bone fastener” lacks consistent antecedent basis.
Dependent claims are also rejected as they include the limitations of their respective parent claim(s).
Appropriate correction is required.
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 pre-AIA 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 –
The following is a quotation of the appropriate paragraphs of pre-AIA 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) the invention was known or used by others in this country, or patented or described in a printed publication in this or a foreign country, before the invention thereof by the applicant for a patent.
Claims 1-3, 5-13 and 15-20 are rejected under pre-AIA 35 U.S.C. 102(a) as being anticipated by Lindemann et al. (2011/0106173; cited by Applicant).
Regarding claim 1, Lindemann et al. disclose a modular fixation system (Fig. 2) comprising:
a fastener 32 including a shaft member 34 and a head 36; and
a tulip assembly (Fig. 2) adapted to be attached to the head 36 of the fastener regardless of whether the fastener is preassembled in the tulip assembly or fixed in a patient bone (see Figs. 2-4 and para. 0036, describing the head being positioned in the receptacle 96 and then held there by retaining member 60; note also that the receiver structure would block insertion from the top), the tulip assembly including:
a tulip 80 having a pair of arms 90, 92 defining a longitudinal axis and forming a channel 94 for receiving a rod 12 (Figs. 2 and 4);
a saddle 220 preassembled in the tulip;
a clamp 250/88 (elements enabling clamping; Fig. 2) attached to the saddle (Fig. 3) and preassembled in the tulip 80 (e.g., portion 250 thereof; while portion 88 is integrally formed with the tulip 80), the clamp including an opening 84 (Fig. 4); and
a uniplanar ring 60 having protrusions 64, 66 inserted into the clamp opening 84 (i.e., along with the ring) and preassembled in the tulip, wherein geometry of the ring 60 enables a uniplanar motion in that it enables the assembled device to operate as a system wherein uniplanar motion between the receiver 80 and the fastener 32 is enabled (para. 0049).
Regarding claim 2, the saddle 220 has an unlocked position and a locked position lower than the unlocked position relative to the tulip 80 (i.e., when the set screw presses the rod and saddle downward), the locked position locking the tulip assembly to the head 36 of the fastener attached to the bone.
Regarding claim 3, the tulip 80 includes an interference protuberance (e.g., the arcuate upper protruding side defining grooves 106, 108 (para. 0036 and annotated Fig. 2, below);
the saddle includes a recess (id.) that receives the interference protuberance in the unlocked position;
wherein when the saddle 220 is pushed downwardly past the interference protuberance (i.e., by action of the set screw; the saddle is pushed down and is already past the interference protuberance and continues to be so after it is pushed down), the saddle is in the locked position and is locked to the head 36 of the fastener 32 attached to the bone.
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Regarding claim 5, the saddle 220 includes a curved top surface to receive the rod 12 (Figs. 2 and 4).
Regarding claim 6, the clamp includes a first clamp portion 250 and a second clamp portion 88 independent from the first clamp portion (Fig. 2).
Regarding claim 7, the uniplanar ring 60 (supra) includes a pair of protrusions 64, 66 that are receivable in opposed openings (i.e., continuous and defined by opposing sides of the opening 84) in portion 80 of the clamp (para. 0036 and Fig. 4).
Regarding claim 8, the protrusions 64, 66 of the uniplanar ring 60 are curved (Fig. 2).
Regarding claim 9, the protrusions 64, 66 are received in curved openings (i.e., curved, continuous and defined by opposing sides of the opening 84) in the clamp (para. 0036 and Fig. 4).
Regarding claim 10, the ring 60 includes a central internal opening for receiving the head 36 of the bone fastener 32 (Fig. 3).
Regarding claim 11, Lindemann et al. disclose a modular fixation system (Fig. 2) comprising:
a fastener 32 including a shaft member 34 and a head 36; and
a tulip assembly (Fig. 2) adapted to be attached to the head 36 of the fastener regardless of whether the fastener is preassembled in the tulip assembly or fixed in a patient bone (see Figs. 2-4 and para. 0036, describing the head being positioned in the receptacle 96 and then held there by retaining member 60; note also that the receiver structure would block insertion from the top), the tulip assembly including:
a tulip 80 having a pair of arms 90, 92 defining a longitudinal axis and forming a channel 94 for receiving a rod 12 (Fig. 200;
a saddle 220 preassembled in the tulip;
a clamp 250/88 (elements enabling clamping; Fig. 2) attached to the saddle (Fig. 3) and preassembled in the tulip 80 (e.g., portion 250 thereof; while portion 88 is integrally formed with the tulip 80), the clamp including an opening 84 (Fig. 4); and
a uniplanar ring 60 having protrusions 64, 66 inserted into the clamp opening 84 (i.e., along with the ring) and preassembled in the tulip, wherein geometry of the ring 60 restricts motion between the fastener 32 and the tulip 80 to uniplanar motion, in that the ring 60 is necessary for the device to operate as a system to restrict motion between the fastener 32 and the tulip 80 to uniplanar motion (para. 0049).
Regarding claim 12, the saddle 220 has an unlocked position and a locked position lower than the unlocked position relative to the tulip 80 (i.e., when the set screw presses the rod and saddle downward), the locked position locking the tulip assembly to the head 36 of the fastener attached to the bone.
Regarding claim 13, the tulip 80 includes an interference protuberance (e.g., the arcuate upper protruding side defining grooves 106, 108 (para. 0036 and annotated Fig. 2, above);
the saddle includes a recess (id.) that receives the interference protuberance in the unlocked position;
wherein when the saddle 220 is pushed downwardly past the interference protuberance (i.e., by action of the set screw; the saddle is pushed down and is already past the interference protuberance and continues to be so after it is pushed down), the saddle is in the locked position and is locked to the head 36 of the fastener 32 attached to the bone.
Regarding claim 15, the saddle 220 includes a curved top surface to receive the rod 12 (Figs. 2 and 4).
Regarding claim 16, the clamp includes a first clamp portion 250 and a second clamp portion 88 independent from the first clamp portion (Fig. 2).
Regarding claim 17, the uniplanar ring 60 (supra) includes a pair of protrusions 64, 66 that are receivable in opposed openings (i.e., continuous and defined by opposing sides of the opening 84) in portion 80 of the clamp (para. 0036 and Fig. 4).
Regarding claim 18, the protrusions 64, 66 of the uniplanar ring 60 are curved (Fig. 2).
Regarding claim 19, the protrusions 64, 66 are received in curved openings (i.e., curved, continuous and defined by opposing sides of the opening 84) in the clamp (para. 0036 and Fig. 4).
Regarding claim 20, the ring 60 includes a central internal opening for receiving the head 36 of the bone fastener 32 (Fig. 3).
Allowable Subject Matter
No claims are currently allowed.
Reasons for Allowance
Claims 4 and 14 in the instant application have not been rejected using prior art because no references, or reasonable combination thereof, could be found which disclose or suggest the claimed combination of limitations recited in claims 4 and 14. In particular, none of the cited references teach or suggest wherein when the saddle is pulled upwardly from the locked fastener head attached to the bone, the recess receives the interference protuberance and releases the fastener head attached to the bone from the tulip assembly, as required by claims 4 and 14.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure (see attached PTO-892).
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
/EDUARDO C ROBERT/Supervisory Patent Examiner, Art Unit 3773