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.
Priority
Acknowledgment is made of applicant's claim for foreign priority based on an application filed in EP on 11/13/2019.
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Should applicant desire to obtain the benefit of foreign priority under 35 U.S.C. 119(a)-(d) prior to declaration of an interference, a certified English translation of the foreign application must be submitted in reply to this action. 37 CFR 41.154(b) and 41.202(e).
Failure to provide a certified translation may result in no benefit being accorded for the non-English application.
Response to Amendment
The amendment filed January 24th, 2026 has been entered. Claims 1-4, 9-1, and 19-24 remain pending in the application. Claims 5 and 6 have been cancelled. New claim 25 has been added.
Response to Arguments
Applicant’s arguments with respect to claims 1 and 24 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.
The device of McMinn has been modified by a new secondary reference to have a coating that comprises of elemental Zr, as by doing so would provide a coating that is more or less defect-free, i.e., also has no so-called "pin holes", through which charges and, in particular, also ions from the implant material can pass into the hard material coating or pass through it as well as layers or ceramics containing zirconium have a particularly great hardness and, therefore, a high abrasion resistance and contributes to an additional reduction in wear and tear as taught by Zeller (see paragraphs [0025], [0026], and [0037]). Regarding the argument that McMinn teaches against a coating that is not oxidized, the Examiner respectfully disagrees. McMinn describing the benefits of using an oxidized zirconium (reducing corrosion) does not exclude the device from potentially being coated by another material that is not oxidized zirconium that reduces corrosion. Additionally, it is taught by Zeller that zirconium coatings have particularly great hardness and, therefore, a high abrasion resistance (see paragraph [0025]), which would also reduce corrosion, as Zeller also teaches that the layers on the implant, one covering layer being potentially of ZrN, causes an improvement in the lubrication of the sliding surfaces and, therefore, contributes to an additional reduction in wear and tear (see paragraph [0026]).
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 limitations use 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 limitations are: “connecting portion” (claims 1, 11, 13) and “connecting portion counterpart” (claim 11).
Because these claim limitations are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, they are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof. The specification discloses that the “connecting portion” (claims 1, 11, 13) and “connecting portion counterpart” (claim 11) can include a male cone (30) having an end face (40) and a female cone (60) having an inner circumferential surface (70), respectively, and vice versa (see pages 10-11 of the instant specification).
If applicant does not intend to have these limitations interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitations to avoid 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 limitations recites sufficient structure to perform the claimed function so as to avoid 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
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim 24 is rejected under 35 U.S.C. 103 as being unpatentable over US 20160278928 A1 (hereafter --Mcminn--) in view of US 20090210068 (hereafter --Zeller--).
Regarding Claim 24, Mcminn discloses an implant component (32, 10), a prosthesis shaft (see annotated shaft in Figure 1 below), the prosthesis shaft comprising a connecting portion (this limitation is being interpreted under 112(f), wherein Mcminn discloses a male cone 10 having an end face; see annotated Figure 1A below), the at least one connecting portion (10) being at least partly coated with a Zr coating and the coating having a thickness of 1-20 um (see paragraphs [0026] and [0032]), in which the Zr coating has a Zr content of at least 90 At. % (see paragraph [0030]).
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McMinn fails to disclose wherein the Zr coating comprises elemental zirconium, and wherein the Zr coating excludes zircon (Zr[SiO4]), zirconium-based minerals, and zirconium-based ceramics.
Zeller discloses an implant for insertion into the human body, in which the implant has a coating on the surface (see Abstract). Zeller teaches wherein the coating comprises elemental zirconium [[0037], wherein the Zr coating excludes zircon (Zr[SiO4]), zirconium-based minerals, and zirconium-based ceramics (see paragraphs [0025] and [0026]).
Therefore, it would have been obvious to one of ordinary skill in the art to have the coating of McMinn comprise of elemental zirconium, wherein the Zr coating excludes zircon (Zr[SiO4]), zirconium-based minerals, and zirconium-based ceramics, as by doing so would provide a coating that is more or less defect-free, i.e., also has no so-called "pin holes", through which charges and, in particular, also ions from the implant material can pass into the hard material coating or pass through it as well as coatings containing zirconium have a particularly great hardness and, therefore, a high abrasion resistance and contributes to an additional reduction in wear and tear, as taught by Zeller (see paragraphs [0025], [0026], and [0037]).
Claims 1-4, 9-18, 20-23, and 25 are rejected under 35 U.S.C. 103 as being unpatentable over US 20160278928 A1 (hereafter --Mcminn--), in view of US 20090210068 (hereafter --Zeller--), in even further view of US 20040236433 A1 (hereafter --Kennedy--).
Regarding Claim 1, Mcminn discloses an implant component (32, 10), a prosthesis shaft (see annotated shaft in Figure 1 below), the prosthesis shaft comprising a connecting portion (this limitation is being interpreted under 112(f), wherein Mcminn discloses a male cone 10 having an end face; see annotated Figure 1A below), the at least one connecting portion (10) being at least partly coated with a Zr coating and the coating having a thickness of 1-20 um (see paragraphs [0026] and [0032]), in which the Zr coating has a Zr content of at least 90 At. % (see paragraph [0030]), and wherein the Zr coating comprises at least one of elemental zirconium and zirconium-based oxides (see paragraphs [0017]-[0018], see also paragraphs [0027]-[0028] and paragraph [0030]), and wherein the implant component is a prosthesis shaft (see annotated implant component 32 and 10 in Figure 1A below), wherein the implant component comprises a cobalt-based alloy (see paragraph [0027]), wherein the implant component comprises a CoCr alloy (see paragraphs [0019], [0027], and [0028]).
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McMinn fails to disclose wherein the Zr coating comprises elemental zirconium, and wherein the Zr coating excludes zircon (Zr[SiO4]), zirconium-based minerals, and zirconium-based ceramics and wherein the CoCr alloy comprises about 62-66% by weight cobalt, about 27-31% by weight chromium, and about 4-5% by weight molybdenum.
Zeller discloses an implant for insertion into the human body, in which the implant has a coating on the surface (see Abstract). Zeller teaches wherein the coating comprises elemental zirconium, wherein the Zr coating excludes zircon (Zr[SiO4]), zirconium-based minerals, and zirconium-based ceramics (see paragraphs [0025] and [0026]; [0037]).
Therefore, it would have been obvious to one of ordinary skill in the art to have the coating of McMinn comprise of elemental zirconium, wherein the Zr coating excludes zircon (Zr[SiO4]), zirconium-based minerals, and zirconium-based ceramics, as by doing so would provide a coating that is more or less defect-free, i.e., also has no so-called "pin holes", through which charges and, in particular, also ions from the implant material can pass into the hard material coating or pass through it as well as coatings containing zirconium have a particularly great hardness and, therefore, a high abrasion resistance and contributes to an additional reduction in wear and tear, as taught by Zeller (see paragraphs [0025], [0026], and [0037]).
Mcminn as modified by Zeller further fails to disclose wherein the CoCr alloy comprises about 62-66% by weight cobalt, about 27-31% by weight chromium, and about 4-5% by weight molybdenum.
Kennedy discloses an implant with a shaft, connecting portion, and a head that is coated with a CoCr alloy (see implant in Figure 1 below). Kennedy teaches wherein the CoCr alloy comprises about 62-66% by weight cobalt, about 27-31% by weight chromium, and about 4-5% by weight molybdenum (see Abstract, see also paragraph [0014]).
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Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the invention to have the CoCr alloy comprise of about 62-66% by weight cobalt, about 27-31% by weight chromium, and about 4-5% by weight molybdenum, as taught by Kennedy, since 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. In re Leshin, 125 USPQ 416.
Regarding Claim 2, Mcminn as modified by Zeller and Kennedy discloses the implant component of claim 1, wherein the coating has a thickness of 3-6 um (see paragraph [0032]).
Regarding Claim 3, Mcminn as modified by Zeller and Kennedy discloses the implant component of claim 1, wherein the connecting portion comprises a female or a male cone (sleeve 10 receives free end of cone 44, thereby comprises a female cone as claimed; see Figure 1A above).
Regarding Claim 4, Mcminn as modified by Zeller and Kennedy discloses the implant component of claim 1, wherein the connecting portion is rotationally symmetrical (see connecting portion in Figure 1A above).
Regarding Claim 9, Mcminn as modified by Zeller and Kennedy discloses the implant component of claim 1, wherein the coating is applied by a physical vapor deposition process (see paragraph [0027]).
Regarding Claim 10, Mcminn as modified by Zeller and Kennedy discloses a modular endoprosthesis (32, 10, 46) comprising an implant component of claim 1 (32, 10).
Regarding Claim 11, Mcminn as modified by Zeller and Kennedy discloses the modular endoprosthesis of claim 10, further comprising a second implant component (46, wherein the at least one implant in this embodiment is considered 32, 10) having a second connecting portion counterpart (this limitation is being interpreted under 112(f) wherein Mcminn discloses a female cone 52 having an inner circumferential surface; see annotated Figure 1A above), said connecting portion counterpart (52) configured to engage with the connecting portion (10) of the implant component (see annotated Figures 1A and 1B above, see also Abstract), wherein said second connecting portion counterpart does not have any Zr coating (see Abstract and paragraphs [0027] and [0034] denoting that the Zr coating is only applied to the recess of the sleeve (connecting portion) 10, such that 46, which includes 52, can be made of traditional materials, see [0056]).
Regarding Claim 12, Mcminn as modified by Zeller and Kennedy discloses the modular endoprosthesis of claim 11, wherein the connecting portion (10) comprises a male cone (see annotated Figure 1A above, wherein 10 is inserted within 52, thereby comprises a male cone as claimed) and the second implant component (46) is a joint head wherein the second connecting portion comprises a female cone (see annotated Figure 1A above, wherein 52 is a conical recess, thereby embodied as a female cone as claimed).
Regarding Claim 13, Mcminn as modified by Zeller and Kennedy discloses a method of preventing corrosion of an implant comprising applying a Zr coating to at least one connecting portion of the implant component (see Abstract) of claim 1, said coating applied to a thickness of 1-20 um (see paragraphs [0027] and [0032]).
Regarding Claim 14, Mcminn as modified by Zeller and Kennedy discloses a method of treating a patient in need of a hip replacement joint who has a metal allergy comprising: implanting the implant component of claim 1 and the implant component is a component of a hip prosthesis (see paragraph [0001] denoting this implant can be used in a total hip replacement procedure).
Regarding Claim 15, Mcminn as modified by Zeller and Kennedy discloses the method of claim 14, wherein the implant is a modular endoprosthesis (see annotated modular endoprosthesis in Figures 1A and 1B above).
Regarding Claim 16, Mcminn as modified by Zeller and Kennedy discloses the implant component of claim 1, wherein the Zr coating has a Zr content of at least 97 At.% (see paragraph [0030]).
Regarding Claim 17, Mcminn as modified by Zeller and Kennedy discloses the implant component of claim 1, wherein the Zr coating has a Zr content of at least 99.5 At.% (see paragraph [0030]).
Regarding Claim 18, Mcminn as modified by Zeller and Kennedy discloses the modular endoprosthesis of claim 10, further comprising a second implant component (46, wherein the at least one implant in this embodiment is considered 32, 10) having a second connecting portion counterpart (this limitation is being interpreted under 112(f) wherein Mcminn discloses a female cone 52 having an inner circumferential surface; see annotated Figure 1A above), said connecting portion counterpart (52) configured to engage with the connecting portion of the implant component, wherein the second connecting portion counterpart comprises an inner circumferential surface, wherein the inner circumferential surface is coated with a second connecting portion Zr coating having a Zr content of at least 90 at.-% (see paragraph [0041] denoting that an internal surface of the recess of the head 52 is coated with zirconium, see also paragraph [0030] regarding the elemental weight 90%), and wherein the second connecting portion Zr coating comprises at least one of elemental zirconium and zirconium-based oxides (see paragraph [0041]).
Regarding Claim 20, Mcminn as modified by Zeller and Kennedy discloses the implant component of claim 1, wherein the Zr coating excludes zircon (Zr[SiO4]), zirconium-based minerals, and zirconium-based ceramics (see paragraph [0057] denoting that the component can be made entirely of zirconium).
Regarding Claim 21, Mcminn as modified by Zeller and Kennedy discloses the implant component of claim 1, wherein the connecting portion comprises an outer circumferential surface and an end face, wherein at least one of the outer circumferential surface and the end face are at least partly coated with the Zr coating (see annotated outer circumferential surface and end face in Figures 1A-1B above). The component 10 of the shaft has an “outer circumferential surface” as well as an “end face,” which would just be the head of the shaft (32,10) that is facing the head 52. Given that the sleeve is disclosed in some embodiments to be completely covered by zirconium (see paragraph [0026]), or made entirely of zirconium (see paragraph [0028]), which would include the outer circumferential surface and end face of the sleeve 10.
Regarding Claim 22, Mcminn as modified by Zeller and Kennedy discloses the implant component of claim 11, wherein the connecting portion comprises an outer circumferential surface and an end face, wherein the second implant component comprises a bottom surface, and wherein the end face and the bottom surface are not in contact (see annotated outer circumferential surface, end face, and bottom surface in Figures 1A-1B above).
Regarding Claim 23, Mcminn as modified by Zeller and Kennedy discloses the implant component of claim 18, wherein the connecting portion comprises an outer circumferential surface and an end face, wherein the second implant component comprises a bottom surface, and wherein the end face and the bottom surface are not in contact (see annotated outer circumferential surface, end face, and bottom surface in Figures 1A-1B above).
Regarding Claim 25, Mcminn as modified by Zeller and Kennedy discloses the implant component of claim 1.
Mcminn as modified by Zeller and Kennedy fails to disclose wherein the implant component further comprises a plastic or a ceramic, wherein the ceramic is one or more ceramics selected from the group consisting of an aluminum-based ceramic, a titanium-based ceramic, a zirconium-based ceramic, and a magnesium-based ceramic.
Zeller teaches wherein the implant component further comprises a plastic or a ceramic, wherein the ceramic is one or more ceramics selected from the group consisting of an aluminum-based ceramic, a titanium-based ceramic, a zirconium-based ceramic, and a magnesium-based ceramic (see paragraphs [0022], [0025], and [0051]).
Therefore, it would have been obvious to one of ordinary skill in the art to have the implant of McMinn the implant component further comprises a plastic or a ceramic, wherein the ceramic is one or more ceramics selected from the group consisting of an aluminum-based ceramic, a titanium-based ceramic, a zirconium-based ceramic, and a magnesium-based ceramic, as it is taught by Zeller that a having ceramic containing zirconium layer is preferred as an intermediate layer, as said material is suitable for sealing the implant material completely (see paragraph [0051]).
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PARIS MARIE BLASS whose telephone number is (703)756-5375. The examiner can normally be reached Monday - Thursday 9 a.m. - 7 p.m. ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melanie Tyson can be reached on 571-272-9062. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/PARIS MARIE BLASS/Examiner, Art Unit 3774
/SARAH W ALEMAN/Primary Examiner, Art Unit 3774
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