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 .
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description: 120'. Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claims 13 and 18 objected to because of the following informalities: " in the claim. 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.
Claim 15 recites the limitation "the base" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim Rejections - 35 USC § 102
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 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) 1-4 and 10 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Patrick (US 2016/0287392 A1).
Regarding claim 1, Patrick discloses a device configured for use as a medical implant (1100, implant, fig. 11A), the device comprising: an anchor body )1108, second par, fig. 11A) comprising a first end (see annotated fig. 11D, below) defining a cavity (see annotated fig. 11D, below), and an elastic articulating component retained within the cavity (1102, hydrogel, fig. 11B), and a second end (see annotated fig. 11D, below) including a fixation element extending cantilevered from the anchor body (1110, screws, fig. 11A).
PNG
media_image1.png
274
323
media_image1.png
Greyscale
Regarding claim 2, Patrick further discloses the second end of the anchor body defines a receptacle (1109, holes, fig. 11D), the fixation element is secured within the receptacle, and the fixation element includes a threaded portion (threads of screw 1110, fig. 11A) that is configured to retain the implant with a patient recipient site (¶ [0144]).
Regarding claim 3, Patrick further discloses a first width (W1) of the cavity is larger than a second width (W2) of the receptacle (figs, 11B and 11D).
Regarding claim 4, Patrick further discloses the fixation element is formed separately from the anchor body (¶ [0143-0144], figs. 11A-11D), and the fixation element further comprises a head portion (see annotated fig. 11D, below) dimensioned to be retained within the receptacle (fig. 11B), and the head portion includes a drive interface (see annotated fig. 11D, below) configured to be engaged by a tool. The phrase “a drive interface configured to be engaged by a tool” is a functional recitation (see MPEP 2114.II). The prior art is not required to explicitly disclose the recited function, but merely have the capability of performing [or being manipulated to] the recited function in order to meet the claim requirements. In this case, the drive interface (see annotated fig. 11D, below) is considered to be capable of being engaged by a tool.
PNG
media_image2.png
274
332
media_image2.png
Greyscale
Regarding claim 10, Patrick further discloses the anchor body further comprises a sidewall (unlabeled sidewall of 1108, fig. 11B) partially defining the cavity, and a collar defining a receptacle (top tapered surface of 1109, fig. 11D), wherein the sidewall and the collar each have an outer surface layer having a porosity configured to promote bone ingrowth (¶ [0142]).
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) 5-6 and 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Patrick.
Regarding claim 5, the first embodiment of Patrick fails to teach the anchor body is configured to be impacted downward to secure the anchor body on to the head portion. However, a second embodiment of Patrick discloses the anchor body (1108, second part, fig. 10B) is configured to be impacted in a downward direction to secure the anchor body onto the head portion (¶ [0138]), and the head portion (1026, wire, fig. 10B) engages against a base of the anchor body in an installed state (fig. 10B). Patrick states embodiments are combinable (¶ [0155]). 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 fixation element of a first embodiment of Patrick to include the anchor body is configured to be impacted downward to secure the anchor body on to the head portion as taught by a second embodiment of Patrick in order to allow the removal of the anchor body without removing the fixation element.
Regarding claim 6, the first embodiment of Patrick fails to teach the fixation element is integral with the anchor body. However, a third embodiment of Patrick discloses the fixation element is formed integrally with the anchor body (fig. 9E). Patrick states embodiments are combinable (¶ [0155]). 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 device of a first embodiment of Patrick to include the fixation elements is integral with the anchor body as taught by a third embodiment of Patrick. It would have been an obvious matter of engineering choice to make the fixation element and the anchor body singular or monolithic, since such a modification would have involved a mere change in the integration of a component. A change in integration or separation of components is generally recognized as being within the level of ordinary skill in the art (MPEP 2144. 04).
Regarding claim 11, the first embodiment of Patrick fails to teach an attachment surface for the fixation element is on a side of the base opposite the surface of the cavity. However, a third embodiment of Patrick discloses the anchor body defines a base (see annotated fig. 9E, below) that partially defines the cavity on a first surface (see annotated fig. 9E, below) and defines an attachment surface (see annotated fig. 9E, below) for the fixation element (930, barb, fig. 9E) on a second, opposite surface (see annotated fig. 9E, below). Patrick states embodiments are combinable (¶ [0155]). 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 device of a first embodiment of Patrick to include an attachment surface for the fixation element is on a side of the base opposite the surface of the cavity as taught by a third embodiment of Patrick since it is combining prior art element according to known methods to yield predictable results, which courts have recognized supports a conclusion of obviousness (see MPEP 2143).
PNG
media_image3.png
247
335
media_image3.png
Greyscale
Claim(s) 7-9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Patrick in view of Gargac (US 2015/0305877 A1).
Regarding claim 7, Patrick fails to teach a Morse taper between the receptacle and a head portion of the fixation element. However, Gargac discloses a bone implant with a connection between an anchor body and a fixation element that includes the anchor body (116, glenosphere, fig. 4) comprises a receptacle having a first tapered profile that is a female Morse taper (248, interior surface, fig. 4, ¶ [0061]), and the fixation element (104 and 108, anchor member and baseplate, fig. 4) comprises a head portion (108, baseplate, fig. 4) having a second tapered profile that is a male Morse taper (156, lateral surface, fig. 4, ¶ [0061]), 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 (¶ [0061]). 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 connection between anchor body and the fixation element of Patrick to include a Morse taper as taught by Gargac in order to improve the strength of the attachment of the anchor body to the fixation element and since is it 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).
Regarding claim 8, Patrick fails to teach the interface region is shorter than the axial length of the threaded portion of the fixation element. However, Gargac further discloses an interface region (IR) is defined between the first and second tapered profiles (see annotated fig. 4, below), and the interface region (IR) is shorter than an axial length (Ls) of a threaded portion of the fixation element (see annotated fig. 4, 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 connection between anchor body and the fixation element of Patrick to include an interface region that is shorter than the axial length of the threaded portion of the fixation element as taught by Gargac in order to improve the strength of the attachment of the anchor body to the fixation element and since is it 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).
PNG
media_image4.png
442
569
media_image4.png
Greyscale
Regarding claim 9, Patrick fails to teach the interface region is at least 50% of an axial depth of the receptacle. However, Gargac further discloses the interface region (IR) is at least 50% of an axial depth of the receptacle (fig. 4). 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 connection between anchor body and the fixation element of Patrick to include an interface region that is at least 50% of an axial depth of the receptacle as taught by Gargac in order to improve the strength of the attachment of the anchor body to the fixation element and since is it 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).
Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Patrick in view of Sikora (US 2015/0250602 A1).
Regarding claim 12, Patrick discloses a base (see annotated fig. 11E, below) that partially defines the cavity on a first surface (see annotated fig. 11E, below).
PNG
media_image5.png
225
352
media_image5.png
Greyscale
Patrick fails to teach an abutment surface for a head portion of the fixation element on a second/opposite surface. However, Sikora discloses a connection between and anchor body (22, body, fig. 12) and a fixation element that includes an abutment surface (see annotated fig. 12, below) for a head portion of the fixation element (94, second fixation element, fig. 12) on a second, opposite surface. 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 added the abutment surface as taught the abutment surface of Sikora to the base of the anchor body as taught by Patrick in order to ensure the fixation element is properly seated and since is a simple matter of design choice and it is combining prior art elements according to known methods to yield predictable results, which courts have recognized supports a conclusion of obviousness (see MPEP 2143).
PNG
media_image6.png
259
247
media_image6.png
Greyscale
Claim(s) 13 and 15-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Patrick in view of Mansmann (US 2018/0289493 A1).
Regarding claim 13 Patrick discloses a device configured for use as a medical implant (1100, implant, fig. 11A), the device comprising:
an anchor body (1108, second part, fig. 11A) including: a first end (see annotated fig. 11D, below) having a sidewall (unlabeled sidewall of 1108, fig. 11B) partially defining a cavity (see annotated fig. 11D, below), and an elastic articulating component (1102, hydrogel, fig. 11A), and a second end (see annotated fig. 11D, below) comprising a collar that is integrally formed with the sidewall (unlabeled top edge of 1109, fig. 11D) and defines a receptacle (1109, holes, fig. 11D)having a first tapered profile that is configured to receive a portion of a fixation element (fig. 11B); and
a fixation element (1110, screws, fig. 11A) including a head portion (see annotated fig. 11D, below) and a threaded portion (see annotated fig. 11D, below), wherein the head portion has a second tapered profile (fig. 11B), and the head portion is configured to be inserted and retained within the receptacle via engagement between the first and second tapered profiles (fig. 11B, ¶ [0143]), and the threaded portion is configured to retain the device with a patient recipient site (¶ [0144]).
PNG
media_image7.png
274
323
media_image7.png
Greyscale
Patrick fails to teach an attachment element. However, Mansmann discloses an anchor that attaches to a flexible element that includes at least one attachment element (40, attachment portion, fig. 4A) configured to retain an 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 attachment mechanism of Patrick to include a lattice attachment element as taught by Mansmann in order to add additional surface area, support and increased retaining surfaces which help retain the flexible material in the anchor (¶ [0117], Mansmann).
Regarding claim 15, Patrick fails to teach the base includes the at least one attachment element. However, Mansmann further discloses the base includes the at least one attachment element configured to retain the elastic articulating component (see annotated fig. 5, 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 device of Patrick to include the base includes the 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 in the anchor (¶ [0117], Mansmann).
PNG
media_image8.png
539
472
media_image8.png
Greyscale
Regarding claim 16, Patrick further discloses a first width (W1) of the cavity is larger than a second width (W2) of the receptacle (figs. 11B and 11D).
Regarding claim 17, the sidewall and the collar both include an outer layer having a porosity configured to promote bone ingrowth (¶ [0142]).
Regarding claim 18, Patrick discloses a device configured for use as a medical implant (1100, implant, fig. 11A), the device comprising:
an anchor body (1108, second part, fig. 11A) including: a first end (see annotated fig. 11D, below) having a sidewall (unlabeled sidewall of 1108, fig. 11B) partially defining a cavity (see annotated fig. 11D, below), and an elastic articulating component (1102, hydrogel, fig. 11A), and a second end (see annotated fig. 11D, below) comprising a collar that is integrally formed with the sidewall (unlabeled top edge of 1109, fig. 11D) and defines a receptacle (1109, holes, fig. 11D)having a first tapered profile that is configured to receive a portion of a fixation element (fig. 11B); and
a fixation element (1110, screws, fig. 11A) including a head portion (see annotated fig. 11D, below) and a threaded portion (see annotated fig. 11D, below), wherein the head portion has a second tapered profile (fig. 11B), and the head portion is configured to be inserted and retained within the receptacle via engagement between the first and second tapered profiles (fig. 11B, ¶ [0143]), and the threaded portion is configured to retain the device with a patient recipient site (¶ [0144]).
PNG
media_image7.png
274
323
media_image7.png
Greyscale
Patrick fails to teach an attachment element. However, Mansmann discloses an anchor that attaches to a flexible element that includes at least one attachment element (40, attachment portion, fig. 4A) configured to retain an 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 attachment mechanism of Patrick to include a lattice attachment element as taught by Mansmann in order to add additional surface area, support and increased retaining surfaces which help retain the flexible material in the anchor (¶ [0117], Mansmann).
Regarding claim 19, Patrick further discloses the sidewall and the collar have a constant outer diameter (fig. 11B), and both include an outer layer having a porosity configured to promote bone ingrowth (¶ [0142]).
Claim(s) 14 and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Patrick in view of Mansmann as applied to claims 14 and 20 above, and further in view of Sikora.
Regarding claims 14 and 20, Patrick in view of Mansmann discloses the anchor body includes a base (Patrick, see annotated fig. 11E, below) that partially defines the cavity on a first surface (Patrick, see annotated fig. 11E, below), and the base defines a second, opposite surface (Patrick, see annotated fig. 11E, below).
PNG
media_image9.png
225
352
media_image9.png
Greyscale
Patrick fails to teach the second surface directly facing the head portion of the fixation element. However, Sikora discloses a connection between and anchor body (22, body, fig. 12) and a fixation element (92, anchor, fig. 12) that includes directly facing the head portion of the fixation element (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 connection between the anchor body and the fixation element of Patrick to include a taper fit where the surface of the base directly faces the head portion for the fixation element as taught by Sikora since it is a combining prior art elements according to known methods to yield predicable results, which courts have recognized supports a conclusion of obviousness (see MPEP 2143).
Conclusion
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 - Friday 7:30 am - 5:00 pm EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, 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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/T.M.D./Examiner, Art Unit 3774
/JERRAH EDWARDS/Supervisory Patent Examiner, Art Unit 3774