Patent Application 15766066 - MEDICAL IMPLANT AND ANCHORING SYSTEM FOR A

Title: MEDICAL IMPLANT AND ANCHORING SYSTEM FOR A MEDICAL IMPLANT

Application Information

Invention Title: MEDICAL IMPLANT AND ANCHORING SYSTEM FOR A MEDICAL IMPLANT
Application Number: 15766066
Submission Date: 2025-05-12T00:00:00.000Z
Effective Filing Date: 2018-04-05T00:00:00.000Z
Filing Date: 2018-04-05T00:00:00.000Z
National Class: 623
National Sub-Class: 020310
Examiner Employee Number: 86827
Art Unit: 3774
Tech Center: 3700

Rejection Summary

102 Rejections: 0
103 Rejections: 2

Cited Patents

The following patents were cited in the rejection:

US 0287392🔗
US 0253474🔗

Office Action Text

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 .
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114 was filed in this application after a decision by the Patent Trial and Appeal Board, but before the filing of a Notice of Appeal to the Court of Appeals for the Federal Circuit or the commencement of a civil action. 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examination under 37 CFR 1.114 and the fee set forth in 37 CFR 1.17(e) has been timely paid, the appeal has been withdrawn pursuant to 37 CFR 1.114 and prosecution in this application has been reopened pursuant to 37 CFR 1.114. Applicant’s submission filed on April 8, 2025 has been entered.
Response to Arguments
Arguments of record regarding patentability of the claimed invention are moot because the new ground of rejection does not rely on the reference as applied in the prior rejections of record for any teaching or matter specifically challenged in the arguments. The rejection is based on a reference provided in the IDS filed with the RCE on April 8, 2025.
Claim Objections
Claim 50 is objected to because of the following informalities: “lattice are” should recite “lattice is”. Appropriate correction is required.
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.

Claims 1-3, 5-7, 9, 14, 16, 50-51, 53-63 and 65 are 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.
Claim 1, line 26, recites “the hydrogel is at least partially received with the array of struts”. The claim is indefinite for recitation of “at least” because the scope or use of the terms suggests that the hydrogel may be fully or entirely received within the array of struts [i.e., rather than just “a portion” as would be the scope of the claim if “at least” were removed from the claim scope]. However, this is contradicted by at least claim 1, lines 22-23, which requires second portion extending out of the top opening,” which portion would not be received within the array of struts.
Claim 54 recites the limitation “an upper edge” in line 3 and “an upper edge” in line 5. Both “upper edge” recitation referring to a portion of “an anchor body”. It is unclear if these two upper edge recitations are regarding a same upper edge or two different upper edges. The claim is indefinite.
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 54-59 are rejected under 35 U.S.C. 103 as being unpatentable over Patrick et al. U.S. publication no. 2016/0287392 A1 (“Patrick”) in view of Klein et al. U.S. publication no. 2012/0253474 A1 (“Klein”).
Regarding claim 54, in an embodiment that combines (see at least paragraph [0155] regarding disclosure for combination of features of different embodiments) features of at least figures 3 and 12C and paragraphs [0080] and [0082] of the disclosure, Patrick discloses an implant for replacement of damaged hyaline cartilage of an articulating joint, the implant comprising: an anchor body (formed by the combination of second 304, seq. and third 306, seq. portions of implant as depicted in combination of figures 3 where bottom of hydrogel 30 is covered by porous second and third portions and figure 12C where porous sidewalls 1224 surround hydrogel 1222). In particular, the formation of the anchor body is achieved by starting with the embodiment depicted in figure 12C further combined to include bottom porous portions 304, 306 to further enhance the implant of figure 12C to include bone ingrowth into bottom porous surface 306. The anchor body (figure 3B portions 304, 306; and figure 12C portion 1224) having a bottom wall (304, 306) and an upper edge (formed by upper edge of 1224) and further comprising: an upstanding perimeter sidewall (1224) having an upper edge (figure 12C), at least a portion (equivalent to porous portion 306, seq.) of the sidewall (1224) including an outer bone attachment layer (106, 306, seq.- paragraph [0082]), a cavity (formed by combining sidewalls 1224 and bottom wall 304) defined by the walls, and a top opening into the cavity (e.g., see at least figure 12C); a lattice (e.g., see at least paragraph [0080], wherein lattice is formed by “titanium mesh”) comprising an array of connected struts (“wires” forming a “bundle of filaments”) extending across and filling [at least] a portion of the cavity and extending along a height of the sidewall between the bottom wall and [including, even if extending beyond a location] below the upper edge, the struts defining an array of pores between surrounding struts (e.g., see at least paragraphs [0020], [0022], [0070], [0080] and [0125]), the pores having a porosity different than a porosity of an outer bone attachment layer (306, seq.) (e.g., see at least paragraph [0082]). The implant further comprising a hydrogel (302, 1222) connected to the anchor body and having a first portion positioned in the cavity of the anchor body (figure 12C), the hydrogel (1222) received within the pores (pores of 304, seq.) defined by the array of struts (paragraphs [0080] and [0082]), the hydrogel (1222) having a second portion (“first portion” 302, seq. of Patrick) extending out of the top opening of the anchor body to define a permanent bearing surface for the damaged hyaline cartilage of the articulating joint (e.g., figures 3B and 12C), wherein the hydrogel (1222) does not contact an outer surface of the sidewall (e.g., figures 3 and 12C and paragraph [0082], etc.).
Patrick expressly teaches:

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However, Patrick is silent regarding an inner barrier layer having a porosity different than pores of the struts and pores of the outer bone attachment layer substantially as claimed.
In the same field of endeavor, namely bone implant devices, throughout the disclosure Klein expressly teaches using an intermediate barrier layer 16 between to porous layers 12 and 14 that are intended to have two different porosities to be used for two different functions in order to prevent migration of material from either of the two different porous layers.
It would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the claimed invention to modify the invention of Patrick to include an intermediate barrier layer, as taught and/or suggested by Klein, between the second and third porous portions of Patrick in order to ensure that each of the two porosities [i.e., porosity of pores of second portion 304, seq. and porosity of pores of third portion 306, seq.] of Patrick may be used for their intended purpose and not inadvertently filed with material intended for the other porous layer.
Regarding claim 55, Patrick in view of Klein, as applied above, teaches the lattice (mesh of Patrick) is connected to an extends from the inner barrier layer (impervious layer of Klein included between inner and outer porous portions 304, 306 of Patrick), and the inner barrier layer (impervious layer of Klein included between inner and outer porous portions 304, 306 of Patrick) provides a barrier between the hydrogel (1222) and the outer bone attachment layer (306, seq.).
Regarding claim 56, Patrick discloses the inner barrier layer (impervious layer of Klein included between inner and outer porous portions 304, 306 of Patrick) is impermeable to hydrogel (e.g., abstract, etc. of Klein).
Regarding claim 57, Patrick discloses the inner barrier layer (impervious layer of Klein included between inner and outer porous portions 304, 306 of Patrick), the lattice (mesh filaments forming layer 304, seq. of Patrick), and the outer bone attachment layer (306, seq. of Patrick)are integrally formed with one another [to form an integral implant for implantation].
Regarding claim 58, Patrick discloses the inner barrier layer (impervious layer of Klein included between inner and outer porous portions 304, 306 of Patrick) is positioned directly between the lattice (mesh filaments forming layer 304, seq. of Patrick) and the outer one attachment layer (306, seq. of Patrick) (e.g., see at least figures 1 and 4 of Klein).
Regarding claim 59, Patrick discloses at least a bottom portion of the sidewall (1224) includes the outer bone attachment layer (equivalent to 304) and the inner barrier layer (16 of Klein between porous layers of Patrick).
Allowable Subject Matter
Claims 64 is allowed.
Claims 1-3, 5-7, 9, 14, 16, 50-51, 53, 60-63 and 65 would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action.
The following is a statement of reasons for the indication of allowable subject matter: among other things, independent claims 1 and 64 along with dependent claims depending therefrom are not rejected under 35 U.S.C. 103 as being unpatentable over Patrick et al. U.S. publication no. 2016/0287392 A1 (“Patrick”) in view of Klein et al. U.S. publication no. 2012/0253474 A1 (“Klein”), as applied above for independent claim 54 along with claims 55-59 depending therefrom, because the claims require “the lattice [struts] does not extend to the upper edge” along with all of the other limitations contained within the claims.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARCIA LYNN WATKINS whose telephone number is (571)270-1456. The examiner can normally be reached Mon. & Tues. 3-8pm and Thurs. 12-6pm.
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/MARCIA L WATKINS/Primary Examiner, Art Unit 3774