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 .
DETAILED ACTION
Election/Restrictions
Applicant’s election without traverse of group I, claims 1-24, Figs. 10-11 in the reply filed on 04/02/2026 is acknowledged. Claims 25-41 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Thus, claims 1-24 are presently pending in this application.
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.
Claim 1 is rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention. It is unclear as to how does a surgical template have a single main body with first, second, third and fourth secondary through holes. Fig. 10 discloses a main body with first and second through holes 72a-72f and Fig. 11 discloses another main body with through holes 172a-172f. However, throughout the disclosure there is no mention of a single main body having all of the first, second, third and fourth secondary through holes. Therefore, it is unclear how the single main body in claim 1 comprises two main bodies where one main body has first and second secondary through holes and the other main body has third and fourth secondary through holes.
Claims 2-24 are rejected as being dependent on a rejected claim.
Claim 19 recites the limitation "the tubular body”. There is insufficient antecedent basis for this limitation in the claim.
Claim 9-11 recite the limitation "said at least one pin”. There is insufficient antecedent basis for this limitation in the claim.
Claim Rejections - 35 USC § 102
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-9, 11-17, 21 and 23-24 are rejected under 35 U.S.C. 102(a)(1) and 102 (a)(2) as being anticipated by Hanson et al. (2011/0125200) “Hanson”.
Regarding claim 1, as best understood, Hanson discloses a template assembly 100 (Fig. 2A) comprising a surgical template 110 including an elongated main body 112/122 (par. 0055 discloses the surgical template 110 can be a single main body or two or more connectable pieces; Fig. 2A); comprising at least one fixing member (pin 20 being inserted in device portal 190; Fig. 2A) configured to cooperate with at least one corresponding fixing seat of at least one rod-shaped and substantially rectilinear rigid primary element (the end of the pin 20 is fully capable of performing this intended use by engaging an implant disclosed in par. 0045 where the implant is fully capable of performing the intended use of having a fixing seat and being rod-shaped and substantially rectilinear rigid primary element),
wherein said main body 112/122 comprises first and second secondary through holes (device portals 128 located in zones Z1 and Z3; Figs. 7A-7B and par. 0065) configured to respectively house thread-like and substantially rectilinear first secondary elements and second secondary elements 20 (par. 0065 discloses device portals 128 receive pins 20 and pins 20 are fully capable of performing the intended use of being thread-like since par. 0009 discloses the use of sutures and par. 0068 discloses the pin 20 can be any materials; Figs. 7A-7B) wherein the first secondary holes define respective first secondary extension directions for the first secondary elements (direction of the lines extending through portals 128 in zone Z3; Figs. 7A-7B) and the second secondary holes define respective second secondary extension directions for the second secondary elements (direction of the lines extending through portals in zone Z1; Figs. 7A-7B), the first and the second secondary extension directions being oblique to one another, preferably orthogonal (as shown in Fig. 7A) and said main body comprises third and fourth secondary through holes (device portals 128 located in left/right opposing zone Z2; Figs. 7A-7B) configured to respectively house thread-like and substantially rectilinear third secondary elements and fourth secondary elements (par. 0065 discloses device portals 128 receive pins 20 and pins 20 are fully capable of performing the intended use of being thread-like since par. 0009 discloses the use of sutures and par. 0068 discloses the pin 20 can be any materials; Figs. 7A-7B), wherein the third secondary holes define respective third secondary extension directions for the third secondary elements, and the fourth secondary holes define respective fourth secondary extension directions for the fourth secondary elements, the third and fourth secondary extension directions being oblique, preferably orthogonal, to one another (as shown in Fig. 7A, the lines passing through device portals 128 in zone Z2 on opposing sides of template 110 are at an oblique angle).
Regarding claim 2, Hanson discloses the first secondary extension directions are substantially parallel to one another and lie in a first plane and the second secondary extension directions are substantially parallel to one another and lie in a second plane (the adjacent lines in zones Z1 and Z3 in Figs. 7A -7B are parallel in direction), said second plane preferably being substantially parallel to said first plane (the planes lying in the transverse direction are parallel; Fig. 7A) or the third secondary extension directions are substantially parallel to one another and lie in a third plane, and the fourth secondary extension directions are substantially parallel to one another and lie in a fourth plane , said fourth plane preferably being substantially parallel to said third plane (as shown in Fig. 7A, zone Z3 has adjacent parallel lines and the planes lying in the transverse directions are parallel).
Regarding claim 3, Hanson discloses wherein the main body 112/122 of the template 110 comprises a central portion extending between two free ends 114/ 124 (Fig. 2A and par. 0055), said free ends extending from the same side of the template with respect to said central portion (U-shaped template 110 has a central portion and two free ends; Fig. 2A).
Regarding claim 4, Hanson discloses wherein a development direction of the main body of the template is contained in a development plane (curved U-shaped plane in Fig. 2A).
Regarding claim 5, Hanson discloses wherein said plane selected from the group consisting of said first plane, and/or said second plane, and/or said third plane, and and/or said fourth plane are substantially parallel to said development plane of the main body of the template (planes extending in the transverse direction are parallel; Fig. 2A).
Regarding claim 6, Hanson discloses wherein the first secondary holes or the third secondary holes are borne by a first rectilinear portion of the template, and the second secondary holes or the fourth secondary holes are borne by a second rectilinear portion extending substantially orthogonal to said first rectilinear portion of the template, the first secondary holes or the third secondary holes extending transversally with respect to said first rectilinear portion of the template and the second secondary holes or the fourth secondary holes extending transversally with respect to said second rectilinear portion of the template (as shown in Fig. 7A, zone Z1 and Z3 extend on opposing rectilinear portions of main body 112 transversally with respect to the portions).
Regarding claim 7, Hanson discloses wherein said first rectilinear portion is defined at the central portion of the main body 112 of the template 110 (zone z3; Fig. 7B) and said second rectilinear portion is defined at one of the free ends 114 of the main body 112 of the template 110 (Fig. 2A).
Regarding claim 8, Hanson discloses wherein said first rectilinear portion and said second rectilinear portion are respectively defined at the free ends of the main body of the template (opposing zones Z1 or Z2 on rectilinear portions 112/122; Figs. 2A and 7B).
Regarding claims 9 and 11, as best understood, Hanson discloses wherein the template 110 comprises at least one pin bearing 180, at one of its proximal ends (Fig. 6A) said at least one fixing member (pin 20; Fig. 6A), said at least one pin extending along a primary extension direction parallel to said development plane of the main body of the template (as shown in Fig. 6A), wherein said at least one pin is borne by a connecting portion extending between the first rectilinear portion and the second rectilinear portion of the main body of the template and is oriented at about 45 degrees with respect to the third secondary extension directions and the fourth secondary extension directions (as shown in Figs. 3 and 7A, the pin 20 is at about a 45 degree angle with respect to Z2).
Regarding claim 12, Hanson discloses wherein the template comprises a first fixing member configured to cooperate with a corresponding first fixing seat of a rod-shaped and substantially rectilinear rigid first primary element and a second fixing member configured to cooperate with a corresponding second fixing seat of a rod-shaped and substantially rectilinear rigid second primary element (Fig. 5, the end of the pins 20 are fully capable of performing this intended use by engaging an implant disclosed in par. 0045 where the implant is fully capable of performing the intended use of having a fixing seat and being rod-shaped and substantially rectilinear rigid primary element).
Regarding claim 13, Hanson discloses wherein the template 110 comprises a first pin bearing said first fixing member at one of its proximal ends said first pin being substantially parallel to said development plane of the main body of the template and a second pin bearing said second fixing member at one of its proximal ends, said second pin being substantially parallel to said development plane of the main body of the template and substantially parallel to said first pin (two pins 20 shown in Fig. 5).
Regarding claims 14-15, Hanson discloses said thread-like and substantially rectilinear first secondary elements inserted in the first secondary holes, or further comprising thread-like and substantially rectilinear third secondary elements inserted in the third secondary holes and further comprising thread-like and substantially rectilinear second secondary elements (inserted in the second secondary holes or further comprising thread-like and substantially rectilinear fourth secondary elements inserted in the fourth secondary holes (pins 20 are inserted in device portals 128; par. 0067).
Regarding claim 16, Hanson discloses a kit 100 (Fig. 2A) of parts for assembling a lattice support structure (Fig 7A and abstract) for one or more degenerated portions of subchondral bone of a bone epiphysis part of a human or animal joint (abstract and par. 0036), said kit of parts comprising: at least one rod-shaped and substantially rectilinear rigid primary element ( implant disclosed in par. 0045 where the implant is fully capable of performing the intended use of being rod-shaped and substantially rectilinear rigid primary element), a plurality of substantially rectilinear thread-like secondary elements comprising first secondary elements and second secondary elements 20 (par. 0065 discloses device portals 128 receive pins 20 and pins 20 are fully capable of performing the intended use of being thread-like since par. 0009 discloses the use of sutures and par. 0068 discloses the pin 20 can be any materials; Figs. 7A-7B) and a template assembly 110 according to claim 1; wherein said at least one primary element has a first transversal dimension greater than a second transversal dimension of said secondary elements and wherein the at least one primary element and the secondary elements are configured to reach and cross at least partially, at both the respective ends cortical bone portions of said bone epiphysis (the cantilevered beam implant in par. 0045 is fully capable of performing this intended use since it is placed in the subchondral bone along with the pins 20).
Regarding claim 17, Hanson discloses wherein said plurality of secondary elements further comprises third secondary elements and fourth secondary elements (zones Z1-Z3; Figs. 7A-7B comprise pins 20).
Regarding claim 21, Hanson discloses wherein the at least one primary element includes a first primary element and a second primary element (par. 0045 discloses plurality of “implants”).
Regarding claims 23 and 24, Hanson discloses wherein the at least one primary element comprises, at an end thereof, a fixing seat for the template, said fixing seat being adapted to cooperate with said fixing member of the template (the end of the pin 20 is fully capable of performing this intended use by engaging an implant disclosed in par. 0045 where the implant is fully capable of performing the intended use of having a fixing seat), wherein an internal lumen of the at least one primary element is configured to receive a filler selected from an autologous bone graft, a homologous bone graft and a synthetic bone graft, said filler preferably being an autologous bone graft, and more preferably comprising autologous stem cells and/or growth factors (the implant in par. 0045 is fully capable of performing this intended use).
Claim Rejections - 35 USC § 103
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.
Claims 18-20 and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Hanson et al. (2011/0125200) “Hanson” in view of Reiley et al. (2011/0087296) “Reiley”.
Hanson discloses the claimed invention of claims 1 and 16; except for wherein the at least one primary element comprises a tubular body with a circular cross section; wherein the tubular body of the at least one primary element bears a plurality of through openings and wherein at least some of the secondary elements are configured to extend through corresponding through openings of the tubular body of the at least one primary element and , wherein the second primary element is configured to extend through corresponding through openings of the tubular body of the first primary element. However, Reiley teaches a similar primary element 20 (Fig. 3) comprising a tubular body with a circular cross section (Fig. 3); wherein the tubular body of the at least one primary element bears a plurality of through openings (par. 0051 discloses through holes 24). The combination of the primary element 20 in Reiley with the secondary elements 20 and primary/secondary elements of Hanson are fully capable of performing the intended use of being configured to extend through corresponding through openings of the tubular body of the at least one primary element and, wherein the second primary element is configured to extend through corresponding through openings of the tubular body of the first primary element. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the primary element in Hanson to include wherein the at least one primary element comprises a tubular body with a circular cross section; wherein the tubular body of the at least one primary element bears a plurality of through openings and wherein at least some of the secondary elements are configured to extend through corresponding through openings of the tubular body of the at least one primary element and , wherein the second primary element is configured to extend through corresponding through openings of the tubular body of the first primary element, as taught and suggested by Reiley, for stabilizing defecting bone region using a bone anchor (abstract of Reiley).
Allowable Subject Matter
Claim 10 is 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 and if amended to overcome the 112 (b) rejection.
The following is a statement of reasons for the indication of allowable subject matter: the subject matter is allowable due to the limitations of “wherein said at least one pin is borne by the first rectilinear portion of the main body of the template and is parallel to the first secondary extension directions” as set forth in claim 10, which has not been found anticipated by or obvious over prior art. Hanson fails to disclose zone Z3 is parallel with the pin 20 inserted through portal 162 (Figs. 2C and 7A-7B).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to YASHITA SHARMA whose telephone number is (571)270-5417. The examiner can normally be reached on 8am-5pm M-Th; 8am-4pm Fri (MT).
If attempts to reach the examiner by telephone are unsuccessful, the examiner' s supervisor, Jerrah Edwards, can be reached at 408-918-7557. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/YASHITA SHARMA/
Primary Examiner, Art Unit 3774
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