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 .
Election/Restrictions
Applicant's election with traverse of Group II, Species 1 in the reply filed on 05/27/2006 is acknowledged. The traversal is on the ground(s) that Species 1 and 2 “should be examined together as the systems illustrated therein, for example, utilize tether 1300 or tether assembly having tether 1300 and a “serious burden” of examining them together does not exist.” This is not found persuasive because Species 1 includes elements 1304, and Species 2 includes ends 1310 and 1308 which differ structurally from Species 1. Applicant is reminded that upon the allowance of a generic claim, applicant will be entitled to consideration of claims to additional species which are written in dependent form or otherwise require all the limitations of an allowed generic claim.
The requirement is still deemed proper and is therefore made FINAL.
Claims 1-117 are pending. Claims 1-23, 40-42, 58-60, 62-75, 89-91, and 93-117 are withdrawn.
Claim Objections
Claims 24 and 36 are objected to because of the following informalities:
In claim 24, line 12, delete “in” after “in”;
In claim 36, line 2, change “slidable” to --slidably--;
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 52-54 and 83-85 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 52 includes the recitation of “a respective additional anchor tether connection location” that is “positioned at a first location offset in a first lateral direction from a midsagittal plane.” The elected embodiment only includes two tether connection locations (see Fig. 1A, elements 1106 and 1206). Additional anchors 1124 and 1224 lack a tether connection location as recited in claims 52 and 83.
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) 24, 26, 36, 38-39, 44-45, 48, 56 and 57 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Schwab (U.S. 2009/0131982 A1).
Concerning claim 24, Schwab discloses a scoliosis treatment system (see Fig. 2) comprising: a first anchor (see Fig. 2 below) configured to install on a posterior region of a first vertebra, the first anchor comprising:
one or more first anchor locations (see Fig. 1 below) at which the first anchor is configured to secure to the first vertebra, and
a first offset connector portion (see Fig. 1 below) fixedly connected to the one or more first anchor locations and extending from the one or more first anchor locations to a first tether connection location (see Fig. 1 below);
wherein the first anchor is configured such that, when the one or more first anchor locations are secured to the first vertebra:
the first tether connection location is positioned at a first location offset in a first lateral direction from a midsagittal plane of the first vertebra, and the first anchor does not include any tether connection locations offset in in a second lateral direction, opposite the first lateral direction, from the midsagittal plane of the first vertebra;
a second anchor (see Fig. 2 below) configured to install on a posterior region of a second vertebra, the second anchor comprising:
one or more second anchor locations at which the second anchor is configured to secure to the second vertebra, and
a second offset connector portion fixedly connected to the one or more second anchor locations and extending from the one or more second anchor locations to a second tether connection location,
wherein the second anchor is configured such that, when the one or more second anchor locations are secured to the second vertebra:
the second tether connection location is positioned at a second location offset in a second lateral direction from a midsagittal plane of the second vertebra, and
the second anchor does not include any tether connection locations offset in in a second lateral direction, opposite the second lateral direction, from the midsagittal plane of the second vertebra; and
a tether (see Fig. 2, element 54) configured to attach to and extend between the first tether connection location and the second tether connection location.
[AltContent: arrow][AltContent: textbox (2nd Anchor)][AltContent: arrow][AltContent: textbox (1st Tether Connection Location )][AltContent: arrow][AltContent: textbox (1st Offset Connector Portion)][AltContent: textbox (1st Anchor Location)][AltContent: arrow][AltContent: textbox (1st Anchor)][AltContent: arrow]
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Concerning claim 26, wherein first tether connection location is configured to be offset in the first lateral direction from the midsagittal plane of the first vertebra relative to all of the one or more first anchor locations when the one or more first anchor locations are secured to the first vertebra; and the second tether connection location is configured to be offset in the first lateral direction from the midsagittal plane of the second vertebra relative to all of the one or more second anchor locations when the one or more second anchor locations are secured to the second vertebra (see Fig. 2, elements 54 and 56 above).
Concerning claim 36, wherein the first tether connection location comprises a first cannulated rod (see Fig. 2, element 36) configured to slidably contain a first tether end.
Concerning claim 38, wherein the tether comprises a metal wire (see par. 0025).
Concerning claim 39, wherein the tether comprises a braided rope (see par. 0025).
Concerning claim 44, the tether (see Fig. 2, element 54) extends from the first tether end (see Fig. 1, element 30 – upper element 20 of Fig. 2) configured to be slidably secured within the first tether connection location (see Fig. 1, element 30), to a second tether end (see Fig. 1, element 30 – lower element 20 of Fig. 2) configured to be secured at the second tether connection location.
Concerning claim 45, wherein the first tether connection location comprises a first cannulated shaft (see Fig. 2, element 36), and the tether is configured to be slidably positioned within the first cannulated shaft.
Concerning claim 48, wherein the first anchor location comprises a threaded screw shaft (see Fig. 1, element 22) and the first offset connector portion comprises a head (28) attached to the threaded screw shaft, the head having a hole or a slot (30) therethrough to slidably receive the first tether end.
Concerning claim 56, wherein the tether comprises a metal wire (see par. 0025).
Concerning claim 57, wherein the tether comprises a braided rope (see par. 0025).
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 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention 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 35 U.S.C. 103 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.
Claim(s) 43, 61 and 92 is/are rejected under 35 U.S.C. 103 as being unpatentable over by Schwab (U.S. 2009/0131982 A1) as applied to claims 24 and 44 above.
Schwab discloses the invention substantially as described above. However, Schwab does not explicitly disclose a document comprising a set of use instructions or instructions for accessing the set of use instruction, the set of use instructions comprising instructions for:
securing the first anchor to the posterior region of the first vertebra; securing the second anchor to the posterior region of the second vertebra; and securing the tether to the first tether connection location and the second tether connection location.
It is noted that it is old and well known in the art of surgical implants to package or supply an implant system with a document setting forth a surgical technique guide, instructions for use, or instructions for accessing such instructions (e.g., a package insert directing the user to an online technique guide), and that such instructions recite the steps by which the implant components are to be secured to the patient’s anatomy and to one another.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have provided the scoliosis treatment system of Schwab with a document comprising such a set of use instructions, in order to convey to the surgeon the intended implantation sequence and thereby promote correct and consistent placement of the anchors and tether. Moreover, the recited instruments merely describe the manner in which the prior art system is already intended to be used – Schwab itself teaches securing the anchors to the posterior regions of the respective vertebrae and coupling the tether to the tether connection locations such that reducing that same procedure to written form would have involved nothing more than the predictable application of a known technique to a known device ready for improvement, yielding predictable results.
Concerning claim 92, it is further noted that the content of the instructions constitutes printed matter that is not functionally related to the underlying apparatus, and therefore is not entitled to patentable weight.
Claim(s) 25, 27-30, 33, 49, 50, 51, 55 is/are rejected under 35 U.S.C. 103 as being unpatentable over by Schwab (U.S. 2009/0131982 A1) as applied to claims 24 and 44 above, in view of Powers et al. (U.S. 2014/0257396 A1).
Schwab discloses the invention substantially as described above. However, Schwab does not explicitly disclose that the one or more first anchor locations comprises at least two first anchor locations configured to secure to the first vertebra on opposite sides of the midsagittal plane of the first vertebra; and the one or more second anchor locations comprises at least two second anchor locations configured to secure to the second vertebra on opposite sides of the midsagittal plane of the second vertebra.
Powers et al. teach two first anchor locations configured to secure to a first vertebra on opposite sides of the midsagittal plane of the first vertebra, and at least two second anchor locations configured to secure to a second vertebra on opposite sides of the midsagittal plane of the second vertebra (see Fig. 1, V4 and V6) in the same field of endeavor for the purpose of treating scoliosis.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Schwab’s system to include two anchor locations on the vertebrae, as disclosed by Powers et al., in order to provide two bone purchase sites that resists rotation and lateral translation. Splitting the corrective load across two points reduces stress at each interface thereby reducing the instance of screw loosening and pullout.
Concerning claims 27-28, Powers et al. discloses the anchor body as including two pedicle screw openings (see Fig. 7). The above described modification of Schwab would result in two pedicle screw openings located on each side of body 20 (see Fig. 2 of Schwab).
Concerning claims 29 and 55, Schwab discloses the invention substantially as described above. However, Schwab does not explicitly disclose a first support anchor configured to install on a posterior region of a third vertebra; a first link configured to fixedly connect between the first support anchor and the first anchor; a second support anchor configured to install on a posterior region of a fourth vertebra; and a second link configured to fixedly connect between the second support anchor and the second anchor.
Powers et al. teach a scoliosis treatment system comprising a first support anchor (see Fig. 6, element 84) configured to install on a posterior region of a third vertebra; a first link (22) configured to fixedly connect between the first support anchor and a first anchor (102 - upper); a second support anchor (92) configured to install on a posterior region of a fourth vertebra; and a second link (28) configured to fixedly connect between the second support anchor and a second anchor (102 – lower).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Schwab’s system to include support anchors and links, as disclosed by Powers et al., in order to tailor the device to the specific patient’s receiving the system thereby providing the needed correction. Furthermore, incorporating support anchors and links reduces system fatigue by distributing load.
Concerning claims 30 and 33, as described above, the modification of Schwab results in the first anchor comprising a first anchor body extending between at least two first anchor locations, and the second anchor comprising a second anchor body extending between at least two second anchor locations.
Allowable Subject Matter
Claims 31, 32, 34, 35, 37, 46-47, 76-82 and 86-88 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ELLEN HAMMOND whose telephone number is (571)270-3819. The examiner can normally be reached Monday-Friday 8 - 4 PM .
If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, Eduardo C. 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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/ELLEN C HAMMOND/Primary Examiner, Art Unit 3773
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