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.
Claim Objections
Claims 1-12 are objected to because of the following informalities:
Claim 1, line 1 recites “Auditory ossicle prosthesis”, which should be “An auditory ossicle prosthesis”.
Claims 2-12 each in line 1 recites “Auditory ossicle prosthesis”, which should be “The auditory ossicle prosthesis”.
Claim 1, line 7 recites “Ball”, which should be “ball”.
Appropriate correction is required.
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 1-12 are 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, line 5 recites the limitation "the human middle ear". There is insufficient antecedent basis for this limitation in the claim. For purposes of examination the Examiner notes this language is being interpreted as “a human middle ear”.
Claim 1, line 5 recites the limitation "the oval window". There is insufficient antecedent basis for this limitation in the claim. For purposes of examination the Examiner notes this language is being interpreted as “an oval window”.
Claim 1, line 11 recites the limitation "the shaft". There is insufficient antecedent basis for this limitation in the claim. For purposes of examination the Examiner notes this language is being interpreted as “a shaft”.
Claim 1, line 12 recites the limitation "the position of use". There is insufficient antecedent basis for this limitation in the claim. For purposes of examination the Examiner notes this language is being interpreted as “a position of use”.
Claim 2, line 3 recites the limitation "the shaft" twice. For each instance, there is insufficient antecedent basis for this limitation in the claim. For purposes of examination the Examiner notes this language is being interpreted as “a shaft” in the first instance of the element. The Examiner notes if the first instance is the element in claim 1 and that rejection is addressed as noted supra, then this rejection becomes moot.
Claim 5, line 4 and Claim 7, line 3 and Claim 8, line 3 each recites the limitation "the pre-load". There is insufficient antecedent basis for this limitation in the claim. For purposes of examination the Examiner notes this language is being interpreted as “a pre-load”.
Claim 5, line 4 and Claim 7, line 3 and Claim 8, line 3 recites the limitation "the eardrum level". There is insufficient antecedent basis for this limitation in the claim. For purposes of examination the Examiner notes this language is being interpreted as “an eardrum level”.
Claim 5, each of lines 4 and 5 and Claim 7, each of lines 3 and 4 and Claim 8, each of lines 3 and 4 recites the limitation "the shaft". There is insufficient antecedent basis for this limitation in the claim. For purposes of examination the Examiner notes this language is being interpreted as “a shaft” in the first instance of the element. The Examiner notes if the first instance is the element in claim 1 and that rejection is addressed as noted supra, then this rejection becomes moot.
Claim 5, line 5 and Claim 7, line 4 and Claim 8, line 4 recites the limitation "the use position". There is insufficient antecedent basis for this limitation in the claim. For purposes of examination the Examiner notes this language is being interpreted as “an use position”.
Claim(s) 3-4, 6, and 9-12 are rejected as dependent from a rejected claim.
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] [a]uditory 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 the human middle ear or on the oval window of a human inner ear (e.g. Figure 2), and
a [b]all 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 the shaft in the 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, 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 the eardrum level 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).
Relevant Prior Art
US 2014/0094910 A1 to Steinhardt, et al teaches an ossicular prosthesis having a foot element, a head element, and a ball joint (e.g. Figure 3).
US 2014/0303728 A1 to Steinhardt, et al teaches an ossicular prosthesis having a foot element, a head element, and a ball joint (e.g. Figure 1b).
US 2018/0064531 A1 to Fjord, et al teaches an ossicular prosthesis having a foot element, a head element, and a connecting means (e.g. Figures 3, 7-8).
US 2009/0164010 A1 to Steinhardt, et al teaches an ossicular prosthesis having a foot element, a head element, and a ball joint (e.g. Figure 1a).
Conclusion
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.
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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 3/5/2026