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 .
Election/Restrictions
Applicant’s election without traverse of Invention I and Species A in the reply filed on 7/30/2026 is acknowledged. The requirement is deemed proper and is therefore made FINAL.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-14 and 21-25 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of U.S. Patent No. 11,071,630. Although the claims at issue are not identical, they are not patentably distinct from each other because all of the structural elements and characteristics are disclosed by both sets of claims. The frame, plurality of beams, open-cell structure, dorsal surface, palmar surface, proximal and distal arms, first and second grooves, and shell of claim 1 of the present application correspond to the frame, plurality of beams, open-cell structure, dorsal surface, palmar surface, proximal and distal arms, first and second grooves, and shell of claim 1 of the patent. The limitations of claim 2 of the application correspond to claim 2 of the patent. The limitations of claim 3 of the application correspond to claim 3 of the patent. The limitations of claim 4 of the application correspond to claim 4 of the patent. The limitations of claim 5 of the application correspond to claim 5 of the patent. The limitations of claim 6 of the application correspond to claim 6 of the patent. The limitations of claim 7 of the application correspond to claim 7 of the patent. The limitations of claim 8 of the application correspond to claims 7 and 8 of the patent. The finger joint, central joint, frame, open-cell structure, dorsal surface, palmar surface, and shell of claim 9 of the present application correspond to the finger joint, central joint, frame, open-cell structure, dorsal surface, palmar surface, and shell of claim 9 of the patent. The limitations of claim 10 of the application correspond to claim 10 of the patent. The limitations of claim 11 of the application correspond to claim 11 of the patent. The limitations of claim 12 of the application correspond to claim 12 of the patent. The limitations of claim 13 where the first channel and second channel of the application correspond to the dorsal groove and palmar groove of claim 13 of the patent. The limitations of claim 14 of the application correspond to claim 14 of the patent. The limitations of claim 21 of the application correspond to claim 1 of the patent. The limitations of claims 22-23 of the application correspond to claims 1 and 8 of the patent. The limitations of claims 24-25 of the application correspond to claims 1 and 7-8 of the patent.
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 14, 25, and their dependent claims 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. Claims 14 and 25 recite the limitation "the first channel." There is insufficient antecedent basis for this limitation in the claim. Claim 25 further recites that the first channel extends from a dorsal opening. It is unclear how this element is distinguished from the first channel opening in the dorsal direction, that is recited in claim 13. Appropriate correction is required.
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, 5, 7-8, and 23-24 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kahn et al. (US Pat. No. 3,886,600; hereinafter “Kahn”).
Kahn discloses the following regarding claim 1: an orthopaedic prosthesis comprising: a frame (160) defined by a plurality of beams (struts of element 160) defining an open-cell structure (Fig. 14; col. 9, lines 24-37), wherein the open-cell structure includes a dorsal surface (upper surfaces), a palmar surface (lower surfaces), and a three-dimensional inner open-cell structure that extends between the dorsal surface and the palmar surface (Figs. 13-14), the open-cell structure including: a proximal arm (144) and a distal arm (145), and (ii) a central body (141) connecting the proximal arm to the distal arm (Figs. 12-14), the central body including a first groove (153) extending into a dorsal end of the central body (Figs. 12-14) and a second groove (164) extending into a palmar end of the central body (Figs. 12-14) positioned opposite the first groove (Figs. 12-13) to permit flexion motion between the proximal arm and the distal arm (col. 8, lines 38-66), and a shell (161, 162) that encases the frame, the shell extending over the proximal arm, the distal arm, and the central body of the frame (Fig. 12; col. 9, lines 38-45).
Kahn discloses the following regarding claim 5: the orthopaedic prosthesis of claim 1, wherein the shell is a silicone coating applied to the frame (col. 10, lines 5-30).
Kahn discloses the following regarding claim 7: the orthopaedic prosthesis of claim 1, wherein: the central body includes a first arcuate section (rounded corners near element 155) and a second arcuate section (rounded corners near element 156) that include a plurality of openings (openings of elements 160) and partially define the first groove (Figs. 12-14), and a third arcuate section (rounded corners near element 141) positioned opposite the first and second arcuate sections (Figs. 12-14) that includes a plurality of openings (openings of elements 160) and partially defines the second groove (Figs. 12-14).
Kahn discloses the following regarding claim 23: the orthopaedic prosthesis of claim 1, wherein the first groove extends from a first groove opening (opening of element 153) formed in the dorsal end of the central body (Figs. 12-14), and the second groove extends from a second groove opening (opening of element 164) formed in the palmar end of the central body (Figs. 12-14).
Kahn discloses the following regarding claim 24: the orthopaedic prosthesis of claim 1, wherein the first groove is defined by a first arcuate section (rounded corners near element 155 at the periphery of the first groove), a first inner surface (inner surface of element 153 located on the side of element 155) extending from the first arcuate section to the dorsal end of the central body (Figs. 12-14), a second arcuate section (rounded corners near element 156), and a second inner surface (inner surface of element 153 located on the side of element 156) extending from the second arcuate section to the dorsal end of the central body (Figs. 12-14).
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 2-3, 9, 11, 13-14, and 25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kahn in view of Hunt (US Pub. No. 2013/0218282).
Regarding claims 2-3 and 9, Kahn discloses the limitations of the claimed invention, as described above. However, it does not recite that the plurality of beams comprising tessellated polyhedrons including as an edge-transitive convex polyhedrons. Hunt teaches that it is well known in the art that orthopedic implants may be provided with frames whose struts form a variety of shapes including tessellated polyhedrons and edge-transitive convex polyhedrons (Figs. 7A-9; paras. 0081, 0111, 0116-0117), for the purpose of providing the implant with bone ingrowth surfaces, and for constructing the implant with the desired structural characteristics needed to suit its implantation site. It would have been obvious to one having ordinary skill in the art to modify the frame and beams of Kahn to comprise the shapes taught by Hunt, in order to provide the implant with bone ingrowth surfaces, and to construct the implant with the desired structural characteristics needed to suit its implantation site. Such a modification would be made with a reasonable expectation of success.
Kahn teaches the following regarding claim 9: an orthopaedic prosthesis comprising: a finger joint implant (140) having a proximal end (144) sized to be positioned in a first finger bone, a distal end (145) sized to be positioned in a second finger bone, and a central joint (141) connecting the proximal end and the distal end (Figs. 12-14), the finger joint implant further comprising: a frame (160) extending from the distal end to the proximal end of the joint implant (Fig. 14; col. 9, lines 24-45), the frame defined by an open-cell structure (Fig. 14), wherein the open-cell structure includes a dorsal surface (upper surfaces), a palmar surface (lower surfaces), and a three-dimensional inner open-cell structure that extends between the dorsal surface and the palmar surface (Figs. 13-14) , the open-cell structure including the central joint, the proximal end, and the distal end (Figs. 12-14), and a shell (161, 162) extending over the proximal end, the distal end, and the central joint to encase the frame (Fig. 12; col. 9, lines 38-45).
Kahn teaches the following regarding claim 11: the orthopaedic prosthesis of claim 9, wherein the shell is a silicone coating applied to the frame (col. 10, lines 5-30).
Kahn teaches the following regarding claim 13: the orthopaedic prosthesis of claim 9, wherein the central joint includes a first channel opening (upper opening for element 152) in the dorsal direction and a second channel (164) positioned opposite the first channel opening in the palmar direction to permit flexion motion between the proximal end and distal end (col. 8, lines 38-66).
Kahn teaches the following regarding claim 14: the orthopaedic prosthesis of claim 13, wherein the central joint includes: a first arcuate section (rounded corners near element 155) and a second arcuate section (rounded corners near element 156) adjacent the first arcuate section that partially define the first channel (Figs. 12-14), and a third arcuate section (rounded corners near element 141) positioned opposite the first and second arcuate sections that partially defines the second channel (Figs. 12-14).
As best interpreted, Kahn teaches the following regarding claim 25: the orthopaedic prosthesis of claim 13, wherein the first channel extends from a dorsal opening (opening or elements 152, 153) formed in a dorsal end of the central joint (Figs. 12-14), and the first channel is at least partially defined by two planar dorsal surfaces (inner side surfaces of elements 152, 153) and two arcuate dorsal surfaces (rounded corner peripheries near elements 155, 156), the two planar dorsal surfaces extending to the dorsal opening from respective arcuate dorsal surfaces (Figs. 12-14).
Claims 4 and 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kahn in view of Hunt, further in view of Pasini et al. (US Pub. No. 2017/0095337; hereinafter “Pasini”).
Kahn, as modified by Hunt, teaches the limitations of the claimed device, as described above. However, they do not recite the frame comprising rhombic dodecahedrons. Pasini teaches that it is well known in the art that orthopedic implants may be provided with frames comprising rhombic dodecahedrons shapes (paras. 0070-0073, 0124), for the purpose of providing the implant with the desired architecture that is based on the requirements of the given implant, application, bone type, patient requirements, etc. It would have been obvious to one having ordinary skill in the art to modify the frame of Kahn and Hunt, to comprise the shapes taught by Pasini, in order to provide the implant with an architecture that is based on the requirements of the given implant, application, bone type, patient requirements, etc. Such a modification would be made with a reasonable expectation of success.
Claim 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kahn in view of Mattes et al. (US Pub. No. 2018/0368981; hereinafter “Mattes”).
Kahn discloses the limitations of the claimed device, as described above. However, it does not recite the frame being a single, monolithic component formed of silicone. Mattes teaches a mesh based, orthopedic implant frame being a single, monolithic component formed of silicone (paras. 0012-0014, 0086, 0096), for the purpose of providing the implant with the desired flexibility needed for its implantation site. It would have been obvious to one having ordinary skill in the art to modify the device of Kahn, to comprise the frame taught by Mattes, in order to provide the implant with the desired flexibility needed for its implantation site. Such a modification would be made with a reasonable expectation of success. In addition, it has been held that held that constructing a modular device into a unitary structure is generally recognized as being within the level of ordinary skill in the art; and a simple substitution of one known element for another to obtain predictable results, in the instant case one type of implant frame material for another, is generally considered to be within the level of ordinary skill in the art.
Claims 8 and 21-22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kahn in view of Niebauer (US Pat. No. 3,593,342).
Kahn discloses the limitations of the claimed prosthesis, as described above. However, it does not explicitly recite the central body including a third inner surface and a fourth inner surface that each include a plurality of openings and extend from the third arcuate section toward the groove opening to partially define the second groove. Niebauer teaches that it is well known in the art that an orthopaedic prosthesis comprises: a central body including a first inner surface (Figures A-B) that includes a plurality of openings (openings at front and back of the groove) and extends from the first arcuate section toward a groove opening (front opening) of the first groove to partially define the first groove (Figures A-B), the second inner surface that includes a plurality of openings (front and back groove openings) and extends from the second arcuate section toward the groove opening of the first groove to partially define the first groove, and a third inner surface (Figures A-B) and a fourth inner surface (Figures A-B) that each include a plurality of openings (front and back second groove openings) and extend from the third arcuate section toward the groove opening (front opening) to partially define the second groove (Figures A-B). The first inner surface extends dorsally from a dorsal edge of the first arcuate section to the groove opening of the first groove (Figures A-B), and the second inner surface extends dorsally from a dorsal edge of the second arcuate section to the groove opening of the first groove (Figures A-B). The first inner surface, the second inner surface, the third inner surface, and the fourth inner surface are planar surfaces (Figure B). This configuration provides the implant with the desired shape, proportions, and degree of motion needed to suit the implantation site (col. 2, lines 26-52). It would have been obvious to one having ordinary skill in the art to modify the shape of the implant of Kahn, according to the teachings of Niebauer, in order to provide the implant with the desired shape, proportions, and degree of motion needed to suit the implantation site. Such a modification would be made with a reasonable expectation of success.
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Figure A.
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Figure B.
Claim 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kahn in view of Hunt, further in view of Mattes.
Kahn, as modified by Hunt, teaches the limitations of the claimed device, as described above. However, they do not recite the frame being a single, monolithic component formed of silicone. Mattes teaches a mesh based, orthopedic implant frame being a single, monolithic component formed of silicone (paras. 0012-0014, 0086, 0096), for the purpose of providing the implant with the desired flexibility needed for its implantation site. It would have been obvious to one having ordinary skill in the art to modify the device of Kahn and Hunt, to comprise the frame taught by Mattes, in order to provide the implant with the desired flexibility needed for its implantation site. Such a modification would be made with a reasonable expectation of success. In addition, it has been held that held that constructing a modular device into a unitary structure is generally recognized as being within the level of ordinary skill in the art; and a simple substitution of one known element for another to obtain predictable results, in the instant case one type of implant frame material for another, is generally considered to be within the level of ordinary skill in the art.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Ann Hu whose telephone number is (571) 272-6652. The examiner can normally be reached on Monday-Friday (9:00 am-5:30 pm EST).
If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, Jerrah Edwards, at (408) 918-7557. The fax phone number for the organization where this application or proceeding is assigned is (571) 273-8300.
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/ANN HU/Primary Examiner, Art Unit 3774
