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 .
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-5 and 7-20 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.
Claim Status
The drawing objection and 35 U.S.C. 112(b) rejection have been overcome.
No changes were made in regard to the claim objections.
Claims 1-5 and 7-20 are examined below.
Claim Objections
Claims 13 and 18 objected to because of the following informalities: Claims 13 and 18 first recite "a fixation element" as a part of functional language the. Appropriate correction is required.
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:
At least one attachment element in claims 13, 15 and 18.
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 § 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 1-5 and 7-12 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 recites “a first end” in line 11, however a first end has already been recited in line 3. It is unclear if this is the same first end or two separate and distinct first ends. The Examiner understands these to be two separate and distinct first ends. Dependent claims 2-5 and 7-12 are likewise rejected.
Claim 1 recites “a second end” in line 12, however a second end has already been recited in line 4. It is unclear if this is the same second end or two separate and distinct second ends. The Examiner understands these to be two separate and distinct second ends. Dependent claims 2-5 and 7-12 are likewise rejected.
Claim 7 recites “a first tapered profile” in line 2. It is unclear if this is the same first tapered profile recited in claim 1 line 6 or a sperate and distinct first tapered profile. The Examiner interprets them to be the same tapered profile and recommends amending “a first tapered profile” to read “the first tapered profile”. Dependent claim 8 is likewise rejected.
Claim 7 recites “a second tapered profile” in line 2. It is unclear if this is the same second tapered profile recited in claim 1 line 11 or a sperate and distinct second tapered profile. The Examiner interprets them to be the same tapered profile and recommends amending “a second tapered profile” to read “the second tapered profile”. Dependent claim 8 is likewise rejected.
Claim 12 recites “a head portion” in line 3. It is unclear if this is the same head portion recited in claim 1 line 11 or a sperate and distinct head portion. The Examiner interprets them to be the same head portion and recommends amending “a head portion” to read “the head portion”.
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.
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(s) 1-2, 4-5, 7-14, 17-18 and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Patrick (US 2016/0287392 A1) in view of Sikora (US 2015/0250602 A1).
Regarding claim 1, Patrick teaches A device configured for use as a medical implant (920, implant, fig. 9E), the device comprising:
an anchor body (928, second part, fig. 9E) comprising a first end defining a cavity (see annotated fig. 9E, below), and a second end opposite the first end (see annotated fig. 9E, below), the anchor body comprising a base positioned between the cavity and the collar (see annotated fig. 9E, below) and having a first surface facing the cavity (see annotated fig. 9E, below), and a second surface opposite the first surface facing away from the cavity (see annotated fig. 9E, below):
an elastic articulating component retained within the cavity (922, hydrogel, fig. 9E).
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Patrick fails to teach a collar defining a receptacle and a fixation element formed separately from the anchor body. However, Sikora teaches a connection between an anchor body and a fixation element that includes an anchor body comprising a collar extending away from the first end (72, cylindrical sidewall, fig. 2) and defining a receptacle (32, first fixation element, fig. 2), the receptacle having a first tapered profile (¶ [0037]): and a fixation element formed separately from the anchor body (94, second fixation element, fig. 3) and comprising a head portion at a first end (95, sidewall, fig. 3) having a second tapered profile complementary to the first tapered profile (¶ [0043]), and a second end opposite the first end (92, first anchor, fig. 3), at least a part of the head portion configured to be received within the receptacle and surrounded at least in part by the collar adjacent to the second surface of the base (fig. 3), the second end of the fixation element extending cantilevered from the anchor body (fig. 3), the head portion positioned on an opposite side of the base from the cavity (fig. 3). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the anchor body of Patrick to include the connection defining a receptacle and a fixation element formed separately from the anchor body as taught by Sikora in order to securely couple the implant to the anchor (¶ [0025], Sikora).
Regarding claim 2, Patrick as modified by Sikora discloses the invention substantially as claimed and as discussed above with respect to claim 1, and additionally teaches the fixation element comprises a threaded portion (102, threads, fig. 3) that is configured to retain the medical implant at a patient recipient site (¶ [0044]).
Regarding claim 4, Patrick as modified by Sikora discloses the invention substantially as claimed and as discussed above with respect to claim 2, and additionally teaches the head portion includes a drive interface (98, driver receptacle, fig. 1) configured to be engaged by a tool (¶ [0045]), and wherein the drive interface is positioned adjacent an aligned opening through the base of the anchor body (fig. 3).
Regarding claim 5, Patrick as modified by Sikora discloses the invention substantially as claimed and as discussed above with respect to claim 4, and additionally teaches the anchor body is configured to be impacted in a downward direction to secure the anchor body onto the head portion (¶ [02227-0028] and ¶[0048]), and the head portion engages against the second surface of the base of the anchor body in an installed state (figs. 3 and 13).
Regarding claim 7, Patrick as modified by Sikora discloses the invention substantially as claimed and as discussed above with respect to claim 1, and additionally teaches the receptacle has a first tapered profile that is a female Morse taper (fig. 3), and the head portion having has a second tapered profile that is a male Morse taper (fig. 3), and the female Morse taper of the receptacle and the male Morse taper of the head portion are configured to secure the anchor body with the fixation element via a cold weld or bond (¶ [0037]).
Regarding claim 8, Patrick as modified by Sikora discloses the invention substantially as claimed and as discussed above with respect to claim 7, and additionally teaches the interface region (IR) is shorter than an axial length (Ls) of a threaded portion of the fixation element (fig. 3).
Regarding claim 9, Patrick as modified by Sikora discloses the invention substantially as claimed and as discussed above with respect to claim 8, and additionally teaches the interface region (IR) is at least 50% of an axial depth of the receptacle (fig. 3).
Regarding claim 10, Patrick further teaches a sidewall at least partially defining the cavity (see annotated fig. 9E, below), and wherein the sidewall and the collar each have an outer surface layer having a porosity configured to promote bone ingrowth (¶ [0142]).
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Regarding claim 11, Patrick as modified by Sikora discloses the invention substantially as claimed and as discussed above with respect to claim 1, and additionally teaches the base partially defines the cavity on the first surface (fig. 9E, Patrick) and defines an attachment surface for the fixation element on the second surface (fig. 13, Sikora).
Regarding claim 12, Patrick as modified by Sikora discloses the invention substantially as claimed and as discussed above with respect to claim 1, and additionally teaches the base partially defines the cavity on the first surface (fig. 9E, Patrick) and defines an abutment surface for a head portion of the fixation element on the second surface (fig. 13, Sikora).
Regarding claim 13, Patrick teaches a device configured for use as a medical implant (920, implant, fig. 9E), the device comprising:
an anchor body (928, second part, fig. 9E) including:
a first end having a sidewall partially defining a cavity (see annotated fig. 9E, below), and at least one attachment element configured to retain an elastic articulating component (932, groove, fig. 9E, ¶ [0135]),
a second end (see annotated fig. 9E, below)
a base positioned between the cavity and the collar (see annotated fig. 9E, below) and having a first surface facing the cavity (see annotated fig. 9E, below), and a second surface opposite the first surface and facing away from the cavity (see annotated fig. 9E, below).
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Patrick fails to teach a collar defining a receptacle and a fixation element formed separately from the anchor body. However, Sikora teaches a connection between an anchor body and a fixation element that includes the anchor body comprising a collar (72, cylindrical sidewall, fig. 2) defining a receptacle (32, first fixation element, fig. 2) having a first tapered profile that is configured to receive a portion of a fixation element (¶ [0037]), and
a fixation element formed separately from the anchor body (94, second fixation element, fig. 3) and including a head portion (95, sidewall, fig. 3)and a threaded portion (102, threads, fig. 3), wherein the head portion has a second tapered profile (¶ [0043]), and the head portion is configured to be inserted and retained within the receptacle via engagement between the first and second tapered profiles (¶ [0037]), and the threaded portion is configured to retain the device at a patient recipient site (¶ [0044]);
wherein the head portion is positioned on an opposite side of the base from the cavity (fig. 3).
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the anchor body of Patrick to include the connection defining a receptacle and a fixation element formed separately from the anchor body as taught by Sikora in order to securely couple the implant to the anchor (¶ [0025], Sikora).
Regarding claim 14, Patrick as modified by Sikora discloses the invention substantially as claimed and as discussed above with respect to claim 13, and additionally teaches the base partially defines the cavity on the first surface (fig. 9E, Patrick), and the second surface directly faces the head portion of the fixation element (fig. 3, Sikora).
Regarding claim 17, Patrick further teaches the sidewall and the collar both include an outer layer having a porosity configured to promote bone ingrowth (¶ [0142], Patrick).
Regarding claim 18, Patrick teaches a device configured for use as a medical implant (920, implant, fig. 9E), the device comprising:
an anchor body (928, second part, fig. 9E) including:
a first end having a sidewall partially defining a cavity (see annotated fig. 9E, below), and at least one attachment element configured to retain an elastic articulating component (932, groove, fig. 9E, ¶ [0135]),
a second end (see annotated fig. 9E, below), and
a base positioned between the cavity and the collar (see annotated fig. 9E, below) and having a first surface facing the cavity (see annotated fig. 9E, below), and a second surface opposite the first surface and facing away from the cavity (see annotated fig. 9E, below)
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Patrick fails to teach a collar defining a receptacle and a fixation element formed separately from the anchor body. However, Sikora teaches a connection between an anchor body and a fixation element that includes the anchor body comprising a collar that is integrally formed with the sidewall (72, cylindrical sidewall, fig. 2) and defines a receptacle (32, first fixation element, fig. 2) having a first tapered profile that is configured to receive a portion of a fixation element (¶ [0037]), and
a fixation element (94, second fixation element, fig. 3) including a head portion (95, sidewall, fig. 3)and a threaded portion (102, threads, fig. 3), wherein the head portion has a second tapered profile (¶ [0043]), and the head portion is configured to be inserted and retained within the receptacle via engagement between the first and second tapered profiles (¶ [0037]), and the threaded portion is configured to retain the device at a patient recipient site (¶ [0044]);
wherein the head portion is positioned on an opposite side of the base from the cavity (fig. 3).
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the anchor body of Patrick to include the connection defining a receptacle and a fixation element formed separately from the anchor body as taught by Sikora in order to securely couple the implant to the anchor (¶ [0025], Sikora).
Regarding claim 20, Patrick as modified by Sikora discloses the invention substantially as claimed and as discussed above with respect to claim 18, and additionally teaches the base partially defines the cavity on the first surface (fig. 9E, Patrick), and the second surface directly faces the head portion of the fixation element (fig. 3, Sikora).
Claim(s) 3, 16 and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Patrick in view of Sikora as applied to claim2, 13 and 18 above, and further in view of Mayer (US 2009/0018560 A1).
Regarding claims 3 and 16, Patrick in view of Sikora fails to teach a first width of the cavity is larger than a second width of the receptacle. However, Mayer teaches a method of attaching an implant to tissue that includes a first width (W1) of the cavity is larger than a second width (W2) of the receptacle (see annotated fig. 1A, below). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the proportions of the cavity and the receptacle of Patrick and Sikora to include a first width (W1) of the cavity is larger than a second width (W2) of the receptacle as taught by Mayer since it is a simple substitution of one known element for another to obtain predictable results, which courts have recognized supports a conclusion of obviousness (see MPEP 2143) and it would have been an obvious matter of design choice to make the different portions of the anchor body of whatever relative sizes were desired, since such a modification would have involved a mere change in the proportions of components. A change in proportion is generally recognized as being within the level of ordinary skill in the art. (see MPEP 2144)
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Regarding claim 19, Patrick further teaches the sidewall and the collar include an outer layer having a porosity configured to promote bone ingrowth (¶ [0142]).
Patrick in view of Sikora fail to teach the sidewall and the collar have a constant outer diameter. However, Mayer further teaches the sidewall and the collar have a constant outer diameter (fig. 1A). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the outer diameter of the sidewall and the collar of Patrick and Sikora to include being constant as taught by Mayer in order to since it is a simple substitution of one known element for another to obtain predictable results, which courts have recognized supports a conclusion of obviousness (see MPEP 2143) and it would have been an obvious matter of design choice to make the different portions of the anchor body of whatever relative sizes were desired, since such a modification would have involved a mere change in the proportions of components. A change in proportion is generally recognized as being within the level of ordinary skill in the art. (see MPEP 2144)
Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Patrick in view of Sikora as applied to claim13 above, and further in view of Mansmann (US 2018/0289493 A1).
Regarding claim 15, Patrick in view of Sikora fails to teach an attachment element. However, Mansmann teaches and anchor that attaches to a flexible element that includes at least one attachment element configured to retain the elastic articulating component (¶ [0117]). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the base of Patrick and Sikora to include at least one attachment element as taught by Mansmann in order to add additional surface area, support and increased retaining surfaces which help retain the flexible material int he anchor (¶ [0117], Mansmann).
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 TERESA M DUDDEN whose telephone number is (571)272-0435. The examiner can normally be reached Monday - Tuesday and Thursday - Friday 7:30 am - 6:00 pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, JERRAH C EDWARDS can be reached 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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/T.M.D./Examiner, Art Unit 3774
/JERRAH EDWARDS/Supervisory Patent Examiner, Art Unit 3774
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