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 .
Information Disclosure Statement
The information disclosure statement filed 8/11/2023 fails to comply with the provisions of 37 CFR 1.97, 1.98 and MPEP § 609 because the international application number does not exist. It has been placed in the application file, but the information referred to therein has not been considered as to the merits. Applicant is advised that the date of any re-submission of any item of information contained in this information disclosure statement or the submission of any missing element(s) will be the date of submission for purposes of determining compliance with the requirements based on the time of filing the statement, including all certification requirements for statements under 37 CFR 1.97(e). See MPEP § 609.05(a).
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-2 and 4 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Jones (US 5,879,387).
Claim 1: Jones discloses a method of making an implantable component for an orthopedic prosthesis (abstract). The method includes molding a first layer of polymeric material to a second layer of polymeric material to form a composite (col. 4, lines 15-23), and forming the composite into a predetermined shape of the implantable component which has an articular layer and a support layer (figs. 3-5; col. 4, lines 15-61), wherein the articular layer includes a homopolymer and the support layer includes a polymer and a reinforcement fiber (col. 2, line 5 – col. 3, line 14).
Claim 2: Jones discloses the implantable component being an acetabular bearing which is adapted to be implanted into an acetabulum of a patient (col. 3, lines 14-20).
Claim 4: Jones discloses the implantable component being a tibial bearing which is adapted to be implanted into a tibia of a patient (fig. 2; col. 4, lines 29-37).
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 1-5 and 7 are rejected under 35 U.S.C. 103 as being unpatentable over King (US 2004/0210316) in view of Jones (US 5,879,387).
Claim 1: King discloses a method of making an implantable component for an orthopedic prosthesis (abstract). The method includes molding a first layer of polymeric material to a second layer of polymeric material to form a composite (Ҟ¶ 29-32; fig. 1), and forming the composite into a predetermined shape of the implantable component which has an articular layer and a support layer (¶¶ 12-14; figs. 2-4), wherein the articular layer includes a homopolymer and the support layer includes a polymer (¶¶ 29-32).
King is silent as to the support layer including a reinforcement fiber. However, in the same field of endeavor, Jones discloses a method of making an implantable component for an orthopedic prosthesis, including molding a first layer of polymeric material to a second layer of polymeric material to form a composite (col. 4, lines 15-23), and forming the composite into a predetermined shape of the implantable component which has an articular layer and a support layer (figs. 3-5; col. 4, lines 15-61), wherein the articular layer includes a homopolymer and the support layer includes a polymer and a reinforcement fiber (col. 2, line 5 – col. 3, line 14). As taught by Jones, a support layer including a reinforcement fiber increases the stability of the prosthesis (col. 2, lines 5 – 45). It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the application to have utilized the support layer of Jones in the component of King to increase the stability of the component.
Claim 2: King discloses the implantable component being an acetabular bearing which is adapted to be implanted into an acetabulum of a patient (¶ 19), and Jones discloses the implantable component being an acetabular bearing which is adapted to be implanted into an acetabulum of a patient (col. 3, lines 14-20).
Claim 3: King discloses the implantable component being a glenoid bearing which is adapted to be implanted into a glenoid of a patient (¶ 19).
Claim 4: King discloses the implantable component being a tibial bearing which is adapted to be implanted into a tibia of a patient (¶ 19), and Jones discloses the implantable component being a tibial bearing which is adapted to be implanted into a tibia of a patient (fig. 2; col. 4, lines 29-37).
Claim 5: King discloses the homopolymer of the articular layer includes PEEK (¶ 29).
Claim 7: King discloses the PEEK being 100% (¶ 29), which is encompassed by the claimed endpoint of about 95%. See Ortho-McNeil Pharm, Inc. v. Caraco Pharm Labs, Ltd., 476 F.3d 1321, 1326, 81 USPQ2d 1427, 1432 (Fed. Cir. 2007) (construing “about 1:5” to encompass a range of ratios of at least 1:3.6 to 1:7.1). Where ranges overlap or are encompassed, a prima facie case of obviousness is made out). In re Boesch, 617 F.2d 272, 275 (CCPA 1980). See also In re Peterson, 315 F.3d 1325, 1329 (Fed. Cir. 2003) (a prima facie case of obviousness exists when the ranges of a claimed composition overlap or encompassed by the ranges disclosed in the prior art) and In re Harris, 409 F.3d 1339, 1341 (Fed. Cir. 2005) (same).
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over King (US 2004/0210316) in view of Jones (US 5,879,387), as applied to claim 1 above, further in view of Buchman (US 2003/0097182).
Claim 6: King is silent as to including polyimide. However, in the same field of endeavor, Buchman discloses a method of making an implantable component for an orthopedic prosthesis, including molding polymeric material including polyimide (title, abstract, ¶¶ 63-65). As taught by Buchman, molding polyimide material for an implantable component for an orthopedic prosthesis creates an artificial orthopedic implant that withstands the natural properties of the joints, including different loads, and resists friction and wear conditions of the human hip or knee joints, as well as provides a solution to late aseptic loosening and to lesser debris generation in order to increase the duration of survival of the implant (¶ 51). It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the application to have included polyimide in the component of King in order to create an artificial orthopedic implant that withstands the natural properties of the joints, including different loads, and resists friction and wear conditions of the human hip or knee joints, as well as provides a solution to late aseptic loosening and to lesser debris generation in order to increase the duration of survival of the implant
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LARRY THROWER whose telephone number is (571)270-5517. The examiner can normally be reached 9am-5pm MT M-F.
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, Susan Leong can be reached at 571-270-1487. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/LARRY W THROWER/ Primary Examiner, Art Unit 1754
Prosecution Insights