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 .
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: bone anchoring part configured to interface in claim 1; cartilage replacing part configured to interface in claim 1.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 103
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.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-3, 5-6, 8, and 10-22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jones (US 2004/0188011) in view of Goldberg et al. (US 2004/0241614), when taken with Jones et al. (US 5,879,387).
Regarding claims 1, 18 and 22: Jones (US ‘011) discloses prosthetic bearing elements [abstract], wherein a hard polyurethane (Bionate 75D) was filled with 15% carbon fibers and injection molded to produce a composite backing [0023-0026]. Jones (US ‘011) discloses injecting molding a soft polyurethane (Bionate 80 A) over the composite backing [0027-0028]. Jones (US ‘011) discloses carbon fibers and zirconia as filler [0022]. Jones (US ‘011) discloses the bearing could be used in a knee and other joints [0003-0004], wherein the bearing can be cemented in [0004], as well as other designs options considered [0028]. Jones (US ‘011) discloses shaping the bearing to match natural condyles to form a bearing insert [0004].
Jones does not specifically disclose the hard polyurethane (Bionate 75D) filled with 15% zirconia. However, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted zirconia for carbon fibers {thereby affording a composite of Bionate 75D and 15 wt% zirconia} based on the invention of Jones (US ‘011), and would have been motivated to do so since Jones (US ‘011) discloses carbon fibers and zirconia as filler [0022]. Additionally, an express suggestion to substitute one equivalent component or process for another is not necessary to render such substitution obvious. In re Fout, 675 F.2d 297, 213 USPQ 532 (CCPA 1982) [see MPEP 2144.06].
Jones (US ‘011) does not disclose zirconia having a particle size of 0.03 – 10 µm. However, Goldberg et al. (US ‘614) discloses composite implants containing fillers, such as zirconia, having a particle size of about 0.1-5.0 microns dispersed in a thermoplastic polyurethane [abstract; 0040; 0056-0057]. Jones (US ‘011) and Goldberg et al. (US ‘614) are analogous art because they are concerned with a similar technical difficulty, namely the preparation of composite implants. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have combined zirconia having a particle size of about 0.1-5.0 microns, as taught by Goldberg et al. (US ‘614) in the invention of Jones (US ‘011), and would have been motivated to do so since Goldberg et al. (US ‘614) suggests zirconia having a particle size of about 0.1-5.0 microns is suitable for dispersion in thermoplastic polyurethane [0056-0057].
Jones et al. (US ‘387) provides evidence for a surgeon cementing in the bearing [1:50-56] and shaping the bearing to match natural condyles to form a bearing insert [claim 6].
Regarding claim 2 and 16: Jones (US ‘011) discloses Bionate 75D [0023], a polycarbonate urethane having a hardness of 75 ShD {see instant specification pg. 53, ln. 18 – pg. 54, ln. 2}.
Regarding claims 3 and 17: Jones (US ‘011) discloses aliphatic polycarbonate polyurethanes prepared from polyether glycols (ex. polytetramethylene ether glycol), 4,4’-methylene biscyclohexane diisocyanate and chain extended with 1,4-butanediol [0004-0005; 0008; 0021-0022].
Jones et al. (US ‘387) provides evidence for aliphatic polycarbonate polyurethanes prepared from polyether glycols (ex. polytetramethylene ether glycol), 4,4’-methylene biscyclohexane diisocyanate and chain extended with 1,4-butanediol [1:65-2:4; 2:15-30; 2:55-66].
Regarding claim 5: Jones (US ‘011) and Goldberg et al. (US ‘614) disclose the basic claimed implant [as set forth above with respect to claim 1].
The claimed effects and physical properties, i.e. a surface texture with a roughness Ra of at least 1 µm, would implicitly be achieved, as “Products of identical chemical composition can not have mutually exclusive properties.” A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990) [see MPEP 2112.01].
Regarding claim 6: Jones (US ‘011) discloses the composite can contain hydroxylapatite [0022].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have included hydroxylapatite based on the invention of Jones (US ‘011), and would have been motivated to do so since Jones (US ‘011) suggests that the composite can contain hydroxylapatite [0022]. Additionally, “It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art.” In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) (citations omitted) [see MPEP 2144.06].
Regarding claim 8: Jones (US ‘011) discloses Bionate 80A [0023], a polycarbonate urethane having a hardness of 80 ShA {see instant specification pg. 53, ln. 18 – pg. 54, ln. 2}.
Regarding claims 10-11: Jones (US ‘011) discloses injecting molding a soft polyurethane (Bionate 80 A) layer having a thickness of 1 to 5 mm over the composite backing [0021; 0027-0028].
Jones et al. (US ‘387) provides evidence for a thickness of 1-5 mm [abstract; 4:15-23; 4:27-54; FIGS. 1-2].
Regarding claim 12: Jones (US ‘011) discloses a structural modification of the hard polyurethane (Bionate 75D) into the soft polyurethane from the interface zone to approximately 50 microns (0.05 mm) into the bulk [0004, 0021, 0027-0028].
Jones et al. (US ‘387) provides evidence for a structural modification of the hard polyurethane (Bionate 75D) into the soft polyurethane from the interface zone to approximately 50 microns (0.05 mm) into the bulk [3:41-52].
Regarding claim 13: Jones (US ‘011) discloses the introduction of barium sulfate (BaSO4) at 5% into the soft polyurethane (Bionate 80 A) to show an interface zone [0004, 0021, 0027-0028].
Jones et al. (US ‘387) provides evidence for introduction of barium sulfate (BaSO4) at 5% into the soft polyurethane to show an interface zone [3:33-40].
Regarding claim 14: Jones (US ‘011) discloses injection molding the backing which leaves a sprue, the backing is removed from the mold and the sprue is removed. A hole is drilled in the backing and the backing is replaced in the mold, and the liner is injection molded by utilizing the hole [0004; 0018; 0021-0027].
Jones et al. (US ‘387) provides evidence for injection molding the backing which leaves a sprue, removing the backing from the mold, removing the sprue, drilling a hole in the backing, replacing the backing in the mold, and injection molding the liner by utilizing the hole [abstract; 4:15-23; 4:27-54; FIGS. 3-4].
Regarding claim 15: Jones (US ‘011) discloses two or more bearing liners [0002-0004].
Jones et al. (US ‘387) provides evidence for two or more bearing liners [3:14-21].
Regarding claims 19-21: Jones (US ‘011) discloses aliphatic polycarbonate polyurethanes having 80 ShA hardness and aliphatic polycarbonate polyurethanes, prepared from polyether glycols (ex. polytetramethylene ether glycol), 4,4’-methylene biscyclohexane diisocyanate and chain extended with 1,4-butanediol [0004-0005, 0008; 0021-0022; 0027].
Jones et al. (US ‘387) provides evidence for aliphatic polycarbonate polyurethanes prepared from polyether glycols (ex. polytetramethylene ether glycol), 4,4’-methylene biscyclohexane diisocyanate and chain extended with 1,4-butanediol [1:65-2:4; 2:15-30; 2:55-66].
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jones (US 2004/0188011) in view of Goldberg et al. (US 2004/0241614) as applied to claim 1 above, and further in view of Elsner et al. (US 2019/0029834).
Regarding claim 9: Jones (US ‘011) and Goldberg et al. (US ‘614) disclose the basic claimed implant [as set forth above with respect to claim 1].
Jones (US ‘011) does not disclose the polyurethanes having an average of 2 hydrophobic endgroups. However, Elsner et al. (US ‘834) discloses prosthetic devices [abstract; 0002] prepared from thermoplastic polyurethanes [0091-0107], wherein the end groups can be modified to hydrophobic endgroups [0097-0099]. Jones (US ‘011) and Elsner et al. (US ‘834) are analogous art because they are concerned with a similar technical difficulty, namely the preparation of prosthetic devices prepared from thermoplastic polyurethanes. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have combined hydrophobic endgroups, as taught by Elsner et al. (US ‘834) in the invention of Jones (US ‘011), and would have been motivated to do so since Elsner et al. (US ‘834) suggests the end groups can be modified to hydrophobic endgroups can enhance key surface properties, such as thromboresistance, biostability and abrasion resistance [0097-0099].
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-20 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.
Jones (US ‘011) was relied on for disclosing prosthetic bearing elements [abstract], wherein a hard polyurethane (Bionate 75D) was filled with 15% carbon fibers and injection molded to produce a composite backing [0023-0026]. Jones (US ‘011) discloses injecting molding a soft polyurethane (Bionate 80 A) over the composite backing [0027-0028]. Jones (US ‘011) discloses carbon fibers and zirconia as filler [0022]. Jones (US ‘011) discloses the bearing could be used in a knee and other joints [0003-0004], wherein the bearing can be cemented in [0004], as well as other designs options considered [0028]. Jones (US ‘011) discloses shaping the bearing to match natural condyles to form a bearing insert [0004].
Jones (US ‘011) discloses carbon fibers and zirconia as filler [0022]. An express suggestion to substitute one equivalent component or process for another is not necessary to render such substitution obvious. In re Fout, 675 F.2d 297, 213 USPQ 532 (CCPA 1982) [see MPEP 2144.06]. Additionally, the selection of a known material based on its suit-ability for its intended use supported a prima facie obviousness determination in Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945) [see MPEP 2144.07].
In response to applicant's argument that Jones (US ‘011) filler is to make it opaque, and not to have it better integrate into bone, the fact that the inventor has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious. See Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985).
While pages 54-56 of the instant specification appear to provide substantial improvements (unexpected results) with respect to the inventive plugs, however, the plugs employed represent implants from specific compositions and are not commensurate in scope with the breadth of implants included in claim 1. As the data obtained from pages 54-56 was obtained from implants of narrower scope than the broad genus of claim 1, it is not possible for the examiner to conclude the data represent unexpected results over the prior art of record [see also MPEP 716.01(c), 716.02(d), 2145; In re Lindner, 457 F.2d 506, 509, 173 USPQ 356, 359 (CCPA 1972); In re Lindner, 457 F.2d 506, 508, 173 USPQ 356, 358 (CCPA 1972)].
Additionally, to establish unexpected results over a claimed range, applicants should compare a sufficient number of tests both inside and outside the claimed range to show the criticality of the claimed range. In re Hill, 284 F.2d 955, 128 USPQ 197 (CCPA 1960) [see MPEP 716.02(d)]. See also In re Lindner, 457 F.2d 506, 509, 173 USPQ 356, 359 (CCPA 1972).
Whether the unexpected results are the result of unexpectedly improved results or a property not taught by the prior art, the “objective evidence of non-obviousness must be commensurate in scope with the claims which the evidence is offered to support.” In other words, the showing of unexpected results must be reviewed to see if the results occur over the entire claimed range. In re Clemens, 622 F.2d 1029, 1036, 206 USPQ 289, 296 (CCPA 1980) [See MPEP 716.02(d)].
Jones (US ‘011) discloses the composite can contain hydroxylapatite [0022]. The hard polyurethane (Bionate 75D) containing hydroxylapatite would have an outer surface comprising bioactive particles, as the resulting composite having the hydroxylapatite dispersed throughout the polyurethane matrix corresponds to the claimed outer surface.
Goldberg et al. (US ‘614) was relied on for disclosing composite implants containing fillers, such as zirconia, having a particle size of about 0.1-5.0 microns dispersed in a thermoplastic polyurethane [abstract; 0040; 0056-0057].
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, Jones (US ‘011) and Goldberg et al. (US ‘614) disclose composite implants. Goldberg et al. (US ‘614) discloses zirconia having a particle size of about 0.1-5.0 microns is suitable for dispersion in thermoplastic polyurethane [0056-0057].
Elsner et al. (US 2019/0029834) was relied on for disclosing prosthetic devices [abstract; 0002] prepared from thermoplastic polyurethanes [0091-0107], wherein the end groups can be modified to hydrophobic endgroups [0097-0099] to enhance key surface properties, such as thromboresistance, biostability and abrasion resistance [0097-0099].
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL F PEPITONE whose telephone number is (571)270-3299. The examiner can normally be reached on 7:00 AM - 3:30 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Mark Eashoo can be reached on 571-272-1197. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICHAEL F PEPITONE/Primary Examiner, Art Unit 1767
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