DETAILED ACTION
This is the first office action on the merits in this application. The claims as amended August 21, 2023, are under consideration. Claims 1-10 were amended and 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 .
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.
Claim 8 is 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. The claim requires a recess structure “configured to increase surface area of the functional element”. Compared to what is the surface area increased? Is this an active step – the recess causes the surface area to actively increase? Or a relative statement – surface area is increased compared to a structure not including a recess structure? Clarification is required. The latter version is what is understood for examination purposes.
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- 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).
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, as best understood, 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 10, 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 tissue part can be inserted (upon insertion of the staple legs into tissue V).
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.
Conclusion
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