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 .
The first inventor to file provisions of the Leahy-Smith America Invents Act (AIA ) apply to any application for patent, and to any patent issuing thereon, that contains or contained at any time—
(A) a claim to a claimed invention that has an effective filing date on or after March 16, 2013 wherein the effective filing date is:
(i) if subparagraph (ii) does not apply, the actual filing date of the patent or the application for the patent containing a claim to the invention; or
(ii) the filing date of the earliest application for which the patent or application is entitled, as to such invention, to a right of priority under 35 U.S.C. 119, 365(a), or 365(b) or to the benefit of an earlier filing date under 35 U.S.C. 120, 121, or 365(c); or
(B) a specific reference under 35 U.S.C. 120 , 121, or 365(c), to any patent or application that contains or contained at any time a claim as defined in paragraph (A), above.
Status of the Claims
Claim(s) 1-12 is/are pending.
Response to Arguments
Applicant’s arguments, filed 3/12/2026, with respect to the claim objections have been fully considered and are persuasive. The objections of claims 1-12 has/have been withdrawn due to the Applicant’s amendments.
Applicant’s arguments, filed 3/12/2026, with respect to the 35 USC 112(b) rejections have been fully considered and are persuasive. The 35 USC 112(b) rejections of claims 1-12 has/have been withdrawn due to the Applicant’s amendments.
Applicant's arguments filed 3/12/2026 have been fully considered but they are not persuasive.
Applicant argues "[m]ere retention of a ball head within a socket does not inherently imply a pre-load condition" (Applicant's Response on 6/12/2026, "Response" herein, page 6). The claim limitation is "with a pre-load perpendicular to the plane of the eardrum or in a longitudinal direction of the shaft in the position of use of the shaft." There is no limitation requiring a particular type or amount of pre-load, thus any pre-load meets the claimed requirement. However, the pre-load option is not required by the claim when the second option is met (i.e. the ball receptacle holds the ball head in a longitudinal direction of the shaft in the position of use of the shaft). This latter option is seen in McGrew's Figure 8.
Applicant argues there is "clearance between the ball portion 78 and the bottom of the generally tubular socket portion 74" as seen in the prior art's Figure 8, and thus there is "play in the longitudinal direction of the shaft assembly" (Response, pages 6-7).
Applicant argues McGrew does not teach "a pre-load to the ball head at all, or any pre-loading or holding the ball portion 78 without any play" (Response, page 7). In addition to the pre-load (and second option) discussed supra, McGrew teaches element #78 pivots within its socket (e.g. column 7, lines 43-52 and lines 53-64). Applicant's original Specification indicates that "without play" allows for pivoting of the ball head (e.g. page 6, lines 12-22 and page 7, lines 4-6). McGrew specifies that longitudinal movement is via the telescoping connection with #81 within #93 (e.g. column 7, lines 43-52). Thus, as claimed, the prior art is disclosed as pivoting in the same manner as the Applicant's disclosed device (i.e. "without play" cannot mean zero movement because Applicant's own disclosed device pivots; if there is zero movement in all rotation directions, there would be no pivoting).
With respect to claim 2, Applicant argues cited Dexon sutures are #110 and not #66 of the prior art (Response, page 8). Applicant argues the prior art does not teach "an elastic pre-loading element on a side of the ball head opposite the shaft, which acts on the ball head in the direction of the shaft" (Response, page 8). The claim requires the ball receptacle as a whole to have "an elastic pre-loading element". There is no claim requirement regarding what this element's particular structure is or where the element is located within the ball receptacle. Therefore, as the cited #66 including its sutures #110, where #110 are elastic and a sub-component of the ball receptacle, meet what is claimed. Applicant has not argued, for example, that cited sutures #110 do not perform the function as cited. The Examiner also notes there is no requirement the elastic element be made solely of elastic material.
With respect to claim 3, Applicant argues the prior art's Figure 2 does not teach "a spring washer arranged tangentially to the ball head" (Response, page 8). The cited "elastic element" is #66 with its sutures #110. The overall cited elastic element is washer shaped (disc shaped).
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
Functional language and intended use language is presented in italicized font.
Claim(s) 1-4 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by McGrew (US 4,601,723 A).
Regarding Claim 1, McGrew teaches an auditory ossicle prosthesis (e.g. abstract, Figures 2-3) comprising:
a head element (e.g. Figures 2-3, #68), configured to be arranged on an eardrum (e.g. Figure 2),
a foot element (e.g. annotated Figure 2 below), configured to be arranged on an auditory ossicle in a human middle ear or on an oval window of a human inner ear (e.g. Figure 2), and
a ball joint (e.g. annotated Figure 2 below; combination of ball head and ball receptacle), which connects the head element and the foot element in an articulated manner (e.g. annotated Figure 2 below), the ball joint having a ball receptacle and a ball head (e.g. annotated Figure 2 below) configured to be pivoted two-dimensionally about its center in the ball receptacle (e.g. Figures 2-3, the ball can rotate in at least two directions), wherein the ball receptacle holds the ball head without play with a pre-load perpendicular to the plane of the eardrum or in a longitudinal direction of a shaft in a position of use of the shaft (e.g. Figures 2-3; the ball head remains in the ball receptacle once implanted and this is “without play” and is positioned as claimed and thus is also play with a pre-load perpendicular to the plane of the eardrum or in a longitudinal direction of the shaft in the position of use of the shaft).
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Annotated Figure 2, McGrew
Regarding Claim 2, McGrew teaches an auditory ossicle prosthesis (e.g. abstract, Figures 2-3) comprising:
a head element (e.g. Figures 2-3, #68), configured to be arranged on an eardrum (e.g. Figure 2),
a foot element (e.g. annotated Figure 2 above), configured to be arranged on an auditory ossicle in a human middle ear or on an oval window of a human inner ear (e.g. Figure 2), and
a ball joint (e.g. annotated Figure 2 above; combination of ball head and ball receptacle), which connects the head element and the foot element in an articulated manner (e.g. annotated Figure 2 above), the ball joint having a ball receptacle and a ball head (e.g. annotated Figure 2 above) configured to be pivoted two-dimensionally about its center in the ball receptacle (e.g. Figures 2-3, the ball can rotate in at least two directions), wherein the ball receptacle holds the ball head without play with a pre-load perpendicular to the plane of the eardrum or in a longitudinal direction of a shaft in a position of use of the shaft (e.g. Figures 2-3; the ball head remains in the ball receptacle once implanted and this is “without play” and is positioned as claimed and thus is also play with a pre-load perpendicular to the plane of the eardrum or in a longitudinal direction of the shaft in the position of use of the shaft),
the ball receptacle has an elastic pre-loading element on a side of the ball head opposite the shaft (e.g. Figures 2-3, column 9, lines 6-25; #66’s Dexon sutures are elastic), which acts on the ball head in the direction of the shaft (by anchoring the device in place it allows force to transfer from the incoming side at the eardrum location toward the ball joint and thus toward the shaft).
Regarding Claim 3, the pre-loading element is a spring washer arranged tangentially to the ball head (e.g. Figure 2).
Regarding Claim 4, the spring washer (10) has a hole, in particular a central hole:(13) or a slot, or in particular slots (14) arranged in a star shape (e.g. Figure 3, holes #72).
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.
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) 5 and 7-8 is/are rejected under 35 U.S.C. 103 as being unpatentable over McGrew (US 4,601,723 A) as discussed supra and further in view of Muller (US 6,540,661 B1).
Regarding Claims 5 and 7-8, McGrew discloses the invention substantially as claimed but fails to teach the ball receptacle has snap elements which are distributed over a circumference, between which the ball head is snapped and which are parallel to the pre-load to the eardrum level or radially to the shaft in the use position of the shaft on the ball head.
Muller teaches an ossicle implant having a ball joint where the ball receptacle has snap elements which are distributed over a circumference (e.g. Figure 3, ball receptacle #38, snap elements #28).
Muller and McGrew are concerned with the same field of endeavor as the claimed invention, namely ossicle implants.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify McGrew such that the ball receptacle has the snap elements as taught by Muller om order to provide a secure and reversible coupling/decoupling means (e.g. Muller, column 8, line 64 to column 9, line 9).
The combination of McGrew and Muller teaches the snap elements are parallel to the pre-load to a level of the eardrum or radially to the shaft in the use position of the shaft on the ball head (e.g. Muller, Figure 3; McGrew, Figure 2; the snap elements are along the direction of the shaft, which is the same direction as the pre-load (see claim 2) and thus are parallel to the pre-load to the eardrum level or radially to the shaft in the use position of the shaft on the ball head).
Claim(s) 6 and 9-11 is/are rejected under 35 U.S.C. 103 as being unpatentable over McGrew (US 4,601,723 A) as discussed supra and further in view of Treace (US 4,281,419 A).
Regarding Claims 6 and 9-11, McGrew teaches the ball head are made of metal or ceramic (e.g. column 7, lines 12-24) and the ball receptacle and the ball head lie directly against one another (e.g. Figures 2-3).
Treace teaches an ear implant ball and socket having both the ball head and the ball receptacle made of metal (e.g. column 4, lines 44-55; Figure 4 shows #10).
Treace and McGrew are concerned with the same field of endeavor as the claimed invention, namely ear implants.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify McGrew such that both the ball head and the ball receptacle are made of a metal as taught by Treace in order to provide a material with both corrosion-resistance and biocompatibility (e.g. Treace, column 4, lines 44-55).
Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over McGrew (US 4,601,723 A) in view of Muller (US 6,540,661 B1) as discussed supra and further in view of Treace (US 4,281,419 A).
Regarding Claims 12, the combination of McGrew and Muller teaches the ball head are made of metal or ceramic (e.g. column 7, lines 12-24) and the ball receptacle and the ball head lie directly against one another (e.g. Figures 2-3).
Treace teaches an ear implant ball and socket having both the ball head and the ball receptacle made of metal (e.g. column 4, lines 44-55; Figure 4 shows #10).
Treace and the combination of McGrew and Muller are concerned with the same field of endeavor as the claimed invention, namely ear implants.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the combination of McGrew and Muller such that both the ball head and the ball receptacle are made of a metal as taught by Treace in order to provide a material with both corrosion-resistance and biocompatibility (e.g. Treace, column 4, lines 44-55).
Conclusion
THIS ACTION IS MADE FINAL. 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 LESLIE A LOPEZ whose telephone number is (571)270-7044. The examiner can normally be reached 8:30 AM - 5:30 PM, MST.
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, THOMAS BARRETT can be reached at (571)272-4746. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LESLIE A LOPEZ/Primary Examiner, Art Unit 3774 7/16/2026
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