DETAILED ACTION
This office action is responsive to the amendment filed April 9, 2026. By that amendment, claims 1 and 8 were amended; claim 10 was canceled; and claims 11-16 were newly presented. Claims 1-9 and 11-16 are pending.
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
The outstanding rejection of claim 8 under 35 USC 112(b) was overcome by the amendment of April 9, 2026.
Applicant's arguments filed April 9, 2026, have been fully considered but they are not persuasive, even in light of the amendment of April 9, 2026. Applicant states that claim 10 was incorporated into claim 1. Examiner also notes that the subject matter of claim 10 was amended to now require “soft tissue” instead of just ‘tissue’.
All of the arguments are based on the amended claim. At p. 6 of the remarks, it is argued that the portions 34 of Michelson engage bone and not soft tissue. Examiner agrees that this is the way the Michelson is demonstrated being used, but does not agree that this makes portions 34 not read on the claimed soft tissue part. There is no reason that portions 34 cannot be passed through soft tissue such that some portion of the soft tissue is capable of being inserted into the grooves in portion 34.
The rejection of record is maintained, below, as modified only to correlate to the amendments to the claims.
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.
Claim(s) 1-9 and 11-16 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Michelson (US 6,120,503).
Regarding claim 1, Michelson teaches a multi-part implant as at fig. 1 comprising:
a support element 40/41 configured for fixing the implant to a bone material V;
wherein a receiving structure 45/43 (e.g. the slot in insertion end 43) of the support element 40/41 forms a receiving space (opening within 45, slot in 43) as seen at fig. 2; and
a functional element 10/11/60 that is configured to be introduced into the receiving space of 45/43;
wherein the functional element 10/11/60 is configured to be fixed in the receiving space of 45/43 by the receiving structure 45/43 at least with respect to one degree of freedom (slot prevents relative rotation between parts, screw 60 prevents relative longitudinal motion between parts); and
the functional element 10/11/60 has a tissue-receiving structure at the segmented structures 34 (of the staple portions 16/17 of 10/11/60) into which a soft tissue part can be inserted (upon insertion of the staple legs into some tissue which is soft tissue, or including a soft-tissue layer).
Once a first alternative is met, additional alternatives in the claim are not required to be shown for the prior art to teach all claimed limitations.
Regarding claim 2, the support element 40/41 is configured as an outer support element, and the receiving space of 45/43 is an interior space partially enclosed by the receiving structure 45/43 (hole 45 is within the structure).
Understood as most reasonably broad, the term “outer support element” is considered to be an intended use. Examiner understands 40/41 to be supporting vertebrae V outside of the support element 40/41.
Regarding claim 3, the support element 40/41 has a window structure 43 through which the functional element 10/11/60 in the receiving space of 43/45 is accessible.
As presently claimed, there is no reason the window structure cannot be part of the receiving space.
Once a first alternative is met, the second alternative in the claim is not required to be present for the prior art to teach all claimed limitations.
Regarding claim 4, the functional element 10/11/60 is made of bioresorbable polymer (col. 15, lines 37-46).
Once a first alternative is met, additional alternatives in the claim are not required to be shown for the prior art to teach all claimed limitations.
Regarding claim 5, a teaching reference is relied upon. As at col. 6, lines 61-65, Michelson US 5,015,247) is referred to in order to provide additional particulars of prior art elements 40/41. That ‘247 reference teaches cylindrical implants being formed of titanium. (Michelson ‘247, col. 8, lines 40-45). Therefore, the support element 40/41 is made from a non-resorbable material, in particular from titanium.
Once a first alternative is met, additional alternatives in the claim are not required to be shown for the prior art to teach all claimed limitations.
Regarding claim 6, the functional element 10/11/60 is configured to be clamped into the receiving space of 45/43 (screw 60 is considered to clamp it therein).
Once a first alternative is met, additional alternatives in the claim are not required to be shown for the prior art to teach all claimed limitations.
Regarding claim 7, the receiving space of 45/43 is formed at least by a turned-back edge of the support element 40/41. The edge of slot 43 is considered to be “turned back” into the body of 40/41.
Regarding claim 8, an interior of the functional element 10/11/60 has at least one recess structure 19 which is configured to inherently increase the surface area of the functional element 10/11/60 relative to a non-countersunk design.
Regarding claim 9, the at least one recess structure 19 comprises at least one cavity in the functional element (formed in portions 10 and 11 of 10/11/60).
Once a first alternative is met, additional alternatives in the claim are not required to be shown for the prior art to teach all claimed limitations.
Regarding claim 11, wherein the support element 40/41 comprises non-resorbable material (titanium, see teaching ref Michelson ‘247, col. 8, lines 42-43); and wherein the functional element 10/11/60 comprises resorbable material (col. 15, lines 37-47).
Regarding claim 12, the resorbable material (e.g. polygalactone or other plastic) is softer than the non-resorbable material (titanium).
Once a first alternative is met, additional alternatives in the claim are not required to be shown for the prior art to teach all claimed limitations.
Regarding claim 13, the support element 40/41 is configured for fixing the implant to the bone material such that the support element 40/41 is capable of positioning the functional element at some inferred soft tissue part – depending on where 40/41 is installed.
Regarding claim 14, the functional element 10/11/60 is configured to at least partially replace and be resorbed by soft-tissue (col. 15, lines 37-47), depending on where 10/11/60 is installed.
Regarding claim 15, the functional element 10/11/60 is porous such that the functional element is configured for blood flow through the functional element (polygalactone is known to be porous; and to become more porous as tissue regrowth occurs); and the support element 40/41 is non-porous such that the support element is configured to limit ingrowth of soft tissue into the support element (titanium is known to be non-porous).
Regarding claim 16, the support element 40/41 defines a plurality of screw holes 45 configured for receipt of inferred fasteners to fix the implant to the bone material; and the functional element 10/11/60 is configured to be clamped and/or clipped into the receiving space by the material of the support element 40/41 (at the groove 44).
Conclusion
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 David Bates whose telephone number is (571)270-7034. The examiner can normally be reached Monday through Friday, 10AM-6PM
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/DAVID W BATES/Primary Examiner, Art Unit 3799
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