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 .
Response to Arguments
Applicant’s arguments with respect to claim(s) below 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. New rejections were made in view of applicant’s amendments. Applicant is welcome to contact the examiner if they have any questions.
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.
Claims 1, 7 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kim US 2017/0086988.
Regarding Claim 1, Kim discloses a system (Fig 12) for treating a spinal disease, said system comprising:
an interbody spacer (#80) which is curved in a horizontal direction (as seen in Fig 14) and used by being inserted between vertebral bodies (Fig 15), the interbody spacer including a pair of contact surfaces (upper and lower surfaces of #80, see Fig below) to be in contact respectively with each of the vertebral bodies (see Fig 14), and including
a ventral surface which is a side surface on a ventral side having a convex shape in plan view (see Fig below, Fig 14) and which connects said pair of contact surfaces on the ventral side (see Fig below, Fig 14), and
a dorsal surface which is a side surface on a dorsal side having a concave shape in plan view (see Fig 14, Fig below) and which connects said pair of contact surfaces on the dorsal side (see Fig 14, Fig below),
the interbody spacer including an engagement portion located on, one of said ventral and dorsal surfaces, and extending along said one of said ventral and dorsal surfaces, which is located along the direction in which the interbody spacer is curved (see Fig below, Fig 14); and
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a guiding tool (#40, Fig 15) for guiding the interbody spacer to a predetermined final position between the vertebral bodies (Fig 15, paragraph 85, 90),
the guiding tool having proximal and distal portions and including, on said distal portion, a guide rail portion (#46, Fig 5d) to be fitted to said engagement portion (paragraph 85, Fig 13b-13c where pusher instrument #70 is coupled to the spacer #80 and has an engagement portion #72 similar to that of engagement portion #82 on the spacer and together engage guide rail portion #46 to insert the spacer)(note if the #82 does not engage #46 then then the spacer #80 would not be able to easily slide along the guiding tool),
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said guide rail portion having a radius of curvature in plan view which is the same as a radius of curvature of said one of said ventral and dorsal surfaces in plan view, and a gripping portion at said proximal portion (see Fig 5d, 15, paragraph 85),
the gripping portion being capable of being gripped by an operator at a location external to the patient to hold said guide rail portion in a fixed position between said vertebral bodies while said interbody spacer is being inserted between said vertebral bodies and being guided by said guide rail portion (as seen in Fig 15, paragraph 85, 90);
wherein one of the transverse cross-section of the engagement portion and the transverse cross- section of the guide rail portion has a concave shape with an opening (see Fig 15, Fig below the engagement portion #82 is complementary to the guide rail portion #46 and that of coupling part #52 located on another spacer #50 and has a concave shape, paragraph 89, it is note that #46 and #52 have the same shape in order for the spacer to be guided by the guiding tool to another spacer #50 and as such guide rail portion #46 would also have a similar opening to that shown in part #52 below), while the other has a convex shape that corresponds to the concave shape of said one of said transverse cross- sections (as seen in Fig 14, Fig above where the engagement portion #82 has a convex shape), and the concave shape of said one of said transverse cross-sections includes a portion having a maximum width that is greater than the width of the opening of said concave shape of said one of said transverse cross-sections (see Fig below, the max width of the portion would be greater than that of the opening, where the portion helps to define part of the opening); and
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wherein said distal portion of the guiding tool is removable from said interbody spacer, by said operator's pulling on said gripping portion, while said interbody spacer remains in said predetermined final position (paragraph 90, Fig 15 where once implanted and the procedure is finished, all tools are removed).
Regarding Claim 7, Kim discloses a method (Fig 15) for insertion of an interbody spacer (#80, discussed in claim 1 above) between vertebral bodies for treatment of a spinal disease, said method comprising: inserting and guiding an interbody spacer according to claim 1 (#80, discussed in claim 1 above) into a final predetermined position between two vertebral bodies (Fig 15, paragraph 90). Examiner notes that the rest of claim 7 is repeated in claim 1 and for expediency, reference is made to claim 1 above.
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.
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.
Claims 2, 5-6, 8, 11-12 are rejected under 35 U.S.C. 103 as being unpatentable over Kim US 2017/0086988 in view of Colleran US 2006/0142858, which claims priority and incorporates by reference (paragraph 1) US Provisional 60/700,861 (reference is made to ‘861).
Kim discloses the claimed invention as discussed above where the engagement portion (#82, Fig 14) is convex (Fig 14) and has an L shape and the guide rail portion is a of a corresponding L shape concave cross section (Fig 5d, see rejection in claim 1) but does not disclose:
wherein the guide rail portion has a maximum transverse width equal to or smaller than the height of the one of said ventral and dorsal surfaces having said engagement portion,
the transverse cross-section of the engagement portion is a T-shaped convex cross-section, and the transverse cross-section of the guide rail portion is a T-shaped concave cross- section.
Colleran ‘861 discloses an interbody spacer (#20’,Fig 10) having a ventral surface (as seen in Fig 10, see Fig below) which is a side surface on a ventral side having a convex shape in plan view (Fig 10-12) and which connects a pair of contact surfaces (top and bottom surfaces of #20’) on the ventral side (see Fig below), the interbody spacer including an engagement portion (see Fig below), which is located along the direction in which the interbody spacer is curved, in one of said ventral (see fig 10-12 fig below) and dorsal surfaces;
wherein said ventral surface engages a rail guide portion (not shown but engages with the engagement portion, paragraph 43 where the engagement portion is a male feature and the guide rail portion is a female slot, examiner notes that the drawings have mislabeled what is the female slot and male rail but as seen in Fig below) to be fitted to said engagement portion of said interbody spacer (see Fig 10-12, paragraph 43), said rail guide portion having a radius of curvature in plan view which is the same as a radius of curvature of said one of said ventral and dorsal surfaces in plan view (Fig 10-12), and
wherein one of the transverse cross-section of the engagement portion and the transverse cross-section of the guide rail portion has a concave shape (see Fig below, the guide rail portion has a concave shape) with an opening (see Figs 6, 8, Fig below paragraph 43, where the female guide rail portion has a T shaped slot, where the skinny part of the “T” defines an opening), while the other has a convex shape that corresponds to the concave shape of said one of said transverse cross-sections (see Fig below, Figs 10-12), and the concave shape of said one of said transverse cross-sections includes a portion (wide portion of the “T” shape of the slot) having a maximum width that is greater than the width of the opening of said concave shape of said one of said transverse cross-sections (see Fig below as discussed above, the slot is T shaped where the skinny part of the “T” is the opening and the wider part of the “T” is the portion with a max width greater than the opening),
where this provides a dovetail connection and allows concave and convex surfaces to be slidably retained to each other (paragraph 36, 43).
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Regarding Claims 2, 8, Colleran discloses the guide rail portion has a maximum transverse width equal to or smaller than the height of the one of said ventral and dorsal surfaces having said engagement portion (with the guide rail portion be in the form of a T-shape slot that engages a corresponding T-shaped male feature on the engagement portion, it would have a maximum transverse width smaller than the height of the ventral surface).
Regarding Claims 5-6, 11-12, Colleran discloses that the transverse cross-section of the engagement portion is a T-shaped convex cross-section (see annotated Figs above and, paragraph 43 in Colleran ‘861 where the engagement portion is a T-shaped male feature on the convex ventral surface), and the transverse cross-section of the guide rail portion is a T-shaped concave cross-section (see annotated Figs above, , paragraph 43 in Colleran ‘861 where the guide rail portion is a corresponding T-shaped slot on concave surface of the guiding tool).
It would have been obvious to one having ordinary skill in the art at a time before the effective filing date of the claimed invention to modify Kim to have the guide rail on the concave surface of the guiding tool include a guide rail portion defining an opening (in the form of a dove tail T-shaped slot) and the engagement portion of the convex ventral surface of the interbody spacer include a T-shaped male feature that engages the opening in view of Colleran ‘861 above because this provides an alternate dovetail connection and allows concave and convex surfaces to be slidably retained to each other. The examiner notes that this modification changes the L-shape of Kim with an alternate T-shape of Colleran ‘861.
Claims 1-4, 7-10 are rejected under 35 U.S.C. 103 as being unpatentable over Garner US 2008/0058933 in view of Colleran US 2006/0142858, which claims priority and incorporates by reference (paragraph 1) US Provisional 60/700,861 (reference is made to ‘861).
Regarding Claim 1, Garner discloses a system (Fig 9a-9d) for treating a spinal disease, said system comprising:
an interbody spacer (#500) which is curved in a horizontal direction (as seen in Fig 9d, Fig below) and used by being inserted between vertebral bodies (Fig 9a-9d), the interbody spacer including a pair of contact surfaces (upper and lower surfaces of #500, one is shown below, the other one is on the opposite side, see Fig below) to be in contact respectively with each of the vertebral bodies (see Fig 9a-9d), and including
a ventral surface which is a side surface on a ventral side having a convex shape in plan view (see Fig below) and which connects said pair of contact surfaces on the ventral side (see Fig below), and
a dorsal surface which is a side surface on a dorsal side having a concave shape in plan view (see Fig below) and which connects said pair of contact surfaces on the dorsal side (see Fig below),
the interbody spacer including an engagement portion (see Fig below, surfaces of #540 and #590 that engage #720, Fig 7) located on, one of said ventral and dorsal surfaces, and extending along said one of said ventral and dorsal surfaces, which is located along the direction in which the interbody spacer is curved (see Fig below); and
a guiding tool (#710) for guiding the interbody spacer to a predetermined final position between the vertebral bodies (see Fig below),
the guiding tool having proximal and distal portions and including, on said distal portion, a guide rail portion (#720, Fig 5d) to be fitted to said engagement portion (see Fig below),
said guide rail portion having a radius of curvature in plan view which is the same as a radius of curvature of said one of said ventral and dorsal surfaces in plan view, and a gripping portion at said proximal portion (see Fig below, where a terminal end of the proximal portion would have a gripping portion),
the gripping portion being capable of being gripped by an operator at a location external to the patient to hold said guide rail portion in a fixed position between said vertebral bodies while said interbody spacer is being inserted between said vertebral bodies and being guided by said guide rail portion (paragraph 47, Fig 9a-9c);
wherein said distal portion of the guiding tool is removable from said interbody spacer, by said operator's pulling on said gripping portion, while said interbody spacer remains in said predetermined final position (paragraph 48 where once implanted and the procedure is finished, all tools are removed and one is able to pull the guiding tool from the disc space).
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Garner discloses wherein one of the transverse cross-section of the engagement portion and the transverse cross- section of the guide rail portion has a concave shape (as discussed above, see Fig 5a, 9d), while the other has a convex shape that corresponds to the concave shape of said one of said transverse cross- sections (as seen in Fig 9d) but does not disclose the concave shape has with an opening and the concave shape of said one of said transverse cross-sections includes a portion having a maximum width that is greater than the width of the opening of said concave shape of said one of said transverse cross-sections.
Colleran ‘861 discloses a system (Figs 10-12) for treating a spinal disease, said system comprising:
an interbody spacer (#10’, Fig 1e) with a dorsal surface (see Fig below) which is a side surface on a dorsal side having a concave shape in plan view (as seen in Fig 10-11) and which connects a pair of contact surfaces (top and bottom surfaces of #10’, Fig 1e) on the dorsal side (see Fig below, Fig 10-11),the interbody spacer including an engagement portion (not shown but engages with the guide rail portion, paragraph 43 where the engagement portion is a female slot, examiner notes that the drawings have mislabled what is the female slot and male rail but as seen in Fig below, the guide rail portion is a male feature), which is located along the direction in which the interbody spacer is curved, in one of said dorsal surface (see Fig below, 10-11), the engagement portion engages with convex surface having a guide rail portion (Fig 10-11) to be fitted to said engagement portion of said interbody spacer (as seen in Fig 10-11 paragraph 43), said guide rail portion having a radius of curvature in plan view which is the same as a radius of curvature of said dorsal surface in plan view (as seen in Fig 10-11),
wherein one of the transverse cross-section of the engagement portion and the transverse cross-section of the guide rail portion has a concave shape (see Fig below, Figs 11-12, paragraph 49, where the female slot is concave in shape to match the convex shape) with an opening (see Figs 6, 8, Fig below paragraph 43, where the female engagement portion has a T shaped slot, where the skinny part of the “T” defines an opening), while the other has a convex shape (see Fig below and discussed above) that corresponds to the concave shape of said one of said transverse cross-sections (Fig 11), and the concave shape of said one of said transverse cross sections includes a portion (wide portion of the “T” shape of the slot) having a maximum width that is greater than the width of the opening of said concave shape of said one of said transverse cross-sections (see Fig below as discussed above, the slot is T shaped where the skinny part of the “T” is the opening and the wider part of the “T” is the portion with a max width greater than the opening),
where this provides a dovetail connection and allows concave and convex surfaces to be slidably retained to each other (paragraph 36, 43).
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It would have been obvious to one having ordinary skill in the art at a time before the effective filing date of the claimed invention to modify Davis to have the engagement portion on the concave dorsal surface of the interbody space include an opening (in the form of a dove tail T-shaped slot) and the guide portion of the guiding tool include a guide rail portion in the form of a male T-shaped rail that engages the opening in view of Colleran ‘861 above because this provides a dovetail connection and allows concave and convex surfaces to be slidably retained to each other. The examiner notes that with this configuration, the dove tail configuration provides a track for the guiding tool to slide along the interbody spacer and provide for a more stable connection as the dovetail connection would run along the length of the interbody space. With the modification, surface #540 of Garner would include the t-shaped opening while guide rail portion that engages with surface #540 would include a corresponding t-shape feature to provide the dovetail connection.
Regarding Claim 7, Garner as modified discloses a method (Fig 9a-9d in Garner) for insertion of an interbody spacer (#500 in Garner, discussed in claim 1 above) between vertebral bodies for treatment of a spinal disease, said method comprising: inserting and guiding an interbody spacer according to claim 1 (#500 in Garner, discussed in claim 1 above) into a final predetermined position between two vertebral bodies (Fig 9d, paragraph 48 in Garner). Examiner notes that the rest of claim 7 is repeated in claim 1 and for expediency, reference is made to claim 1 above.
Regarding Claims 2, 8, Garner as modified discloses the guide rail portion has a maximum transverse width equal to or smaller than the height of the one of said ventral and dorsal surfaces having said engagement portion (with the modification in view of Colleran ‘861 where the guide rail portion is received in the opening of the engagement portion, the guide rail portion would have a maximum transverse width that is equal to or smaller than the height of the dorsal surface).
Regarding Claim 3-4, 9-10, Garner as modified discloses that the transverse cross-section of the engagement portion is a T-shaped concave cross-section (as discussed above with the modification in view of Colleran ‘861, the opening in the concave section is a t-shaped slot to provide a dove tail connection Figs 4, 6 in Colleran ‘861, paragraph 43), and the transverse cross-section of the guide rail portion is a T-shaped convex cross section (as discussed above, the guide rail is modified to have a corresponding T-shaped convex cross section that forms a dove tail connection with the engagement portion).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See PTO-892 which shows a spacer and guiding tool (Fig 9d in Biedermann).
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 JAN CHRISTOPHER L MERENE whose telephone number is (571)270-5032. The examiner can normally be reached Mon-Fri 8:30 am - 6pm EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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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/JAN CHRISTOPHER L MERENE/ Primary Examiner, Art Unit 3773