DETAILED ACTION
This office action is responsive to the amendment and request for continued examination filed September 22, 2026. Claim 1 was amended; and claims 17 and 18 were newly presented. Claims 1-9 and 11-18 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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on September 22, 2026, has been entered.
Response to Arguments
Applicant’s arguments with respect to the rejection of claim(s) 1-9 and 11-16 under 35 USC 102(1)(1) in view of Michelson (US 6,120,503) 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.
As agreed in the examiner interview of September 16, 2026, the amendments to the claims overcome the rejection of record and necessitate further search and consideration. The following rejections are necessitated by the amendments of September 22, 2026.
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) 1-4, 6-9, 13, 14, 16 and 17 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Larsen et al. (US 2017/0231767 A1).
Regarding claim 1, Larsen teaches a multi-part implant 100 as at fig. 1 comprising:
a support element 102 configured for fixing the implant to a bone material [0016];
wherein a receiving structure (inner surfaces of 102) of the support element 102 forms a receiving space (open space inside 102); and
a functional element 104 that is configured to be introduced into the receiving space of 102 (slid in to the space [0016]; see figs. 3-5);
wherein the functional element 104 is configured to be fixed in the receiving space by the receiving structure of 102 at least with respect to one degree of freedom,
wherein the functional element 104 has a tissue-receiving structure 106 into which a soft tissue part (e.g. graft material) is insertable and/or through which the soft tissue part is guidable, and
wherein the multi-part implant is configured as an onlay implant such that the functional element is shaped to bear on the bone material when the support element fixes the implant to the bone material [0016].
Regarding claim 2, the support element 102 is configured as an outer support element, and the receiving space is an interior space partially enclosed by the receiving structure 102.
Regarding claim 3, the support element 102 has a window structure or a rib structure, as seen clearly in fig. 3, through which the functional element 104 in the receiving space is accessible.
Regarding claim 4, the functional element 104 is made of bioresorbable polymer [0021].
Regarding claim 6, the functional element 104 is configured to be clamped into the receiving space of 102 (by the closing step of 102; e.g. being held closed by sutures will cause 102 to clamp against 104 [0016]; [0024].
Regarding claim 7, the receiving space of 102 is formed at least by a turned-back edge of the support element 102 (the edges 116 are considered “turned back” based on the “c-shape” of 102).
Regarding claims 8 and 9, an interior of the functional element 104 has at least one recess structure 144/142/140 as seen in fig. 5 which is configured to increase the surface area of the functional element relative to the interior of the functional element 104 without the at least one recess structure (see fig. 4 vs 5; fig. 5 version includes cavities between additional struts 144/142/140 which increase this surface area of 104 relative to the fig. 4 version).
Regarding claim 13, the support element 102 is configured for fixing the implant 100 to the bone material such that the support element positions the functional element 104 at the soft tissue part (e.g. the cancellous bone portion of the bone) [0016].
Regarding claim 14, the functional element 104 is configured to at least partially replace and be resorbed by soft-tissue.
Regarding claim 16, the support element 102 defines a plurality of screw holes configured for receipt of fasteners to fix the implant 100 to the bone material [0025]; and the functional element 104 is configured to be clamped into the receiving space of 102 by the material of the support element (when closed, as by sutures).
Regarding claim 17, the tissue-receiving structure 106 comprises a channel shaped for receipt of the soft tissue part (openings through 106).
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.
Claim(s) 5, 11, 12, 15 and 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Larsen.
Regarding claims 5, 11, 12 and 15, Larsen teaches the limitations of claim 1, as above. However, Larsen does not teach the support element 102 being made from one of the list of materials or non-resorbable material.
Larsen does discuss desire to improve fixation of the device [0025] as by
inserting bone screws therethrough; use with bone plates [0027], etc. Therefore, the entire device being resorbable is not considered a key feature of Larsen’s structure.
It would have been obvious to one with ordinary skill in the art at the time of the invention to form Larsen’s support element 102 of a material which is in the list of claim 5 as a matter of increasing structural strength, retention of 102 relative to the bone (e.g. strength of resilience of 102), and other material properties of the device. Such a material is considered less-soft than the resorbable material, and non-porous. It has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice.
Regarding claim 18, the limitation of claim 17 were taught by Larsen, as above. Further, the functional element 104 has a planar structure at the struts, thereof. The planar structure of the struts form the claimed channel.
Larsen fails to teach a particular thickness of the planar structure.
It would have been obvious to one with ordinary skill in the art at the time of the invention to form the struts of Larsen such that they have a planar structure of the claimed sizes. One would have done so as a matter of forming the Larsen device to have a desired strength and material properties. Modification for a particular patient’s anatomy, and configuration of the damaged bone, would have been within the general skill of a worker in the art.
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
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, please contact the examiner’s supervisor, Kevin Truong, at (571)272-4705. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/DAVID W BATES/Primary Examiner, Art Unit 3799
