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 .
Response to Arguments
Applicant's arguments filed 10/13/25 have been fully considered but they are not persuasive.
On page 6 regarding drawing objections, Applicant argues amendments overcome the objections of record.
The Examiner respectfully agrees and withdraws drawing objections.
On pages 6-7 regarding prior art rejections Applicant argues the Examiner misinterprets Lim [0020] and [0022]-[0023]. Applicant argues Lim taches wires 30a-b embedded in a body 40 of elastomeric material to form a ring 10, and does not teach that there are portions about the circumference of the ring that have only elastomeric material, which do not have wires. Applicant argues Lim teaches parts of the ring have different flexibility by carrying the spacing between wires 30a-b. Applicant argues accordingly, and based on amendments, the rejections are overcome.
The Examiner respectfully disagrees that the Examiner has misinterpreted anything, noting no part of the claim which requires “portions about the circumference of the ring that have only elastomeric material which do not have wires” as is argued. The Examiner refers Applicant to the rejection below regarding amended claims.
Claim Objections
Claims 1-2 and 8 are objected to because of the following informalities:
Claim 1 is objected to for referring to a portion without “metal” and sections that comprise “metal”, when it is unclear whether or not this “metal” is the same or different metal from one another.
Claims 2 and 8 are objected to for referring to “polymer” when it is unclear if this is the same polymer, or a different polymer than the “polymer” recited by claim 1.
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 1-2, 4-8 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 pre-AIA the applicant regards as the invention.
Claim 1 is indefinite for claiming “at least one portion that is without metal”, when it is unclear how/whether this “at least one portion” relates to the previously claimed “flexible portions”. It is unclear whether or not this is intended to be referring to “at least one of the one or more flexible portions”, or whether this is a distinct “portion” of the core, or some other explanation.
Remaining claims are rejected for depending on an indefinite claim.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-2, 4-8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lim et al. (US 20050256569 A1) hereinafter known as Lim in view of Brunnett et al. (US 20120136435 A1) hereinafter known as Brunnett.
Regarding claim 1 Lim discloses an annuloplasty ring ([0002]) comprising:
a core defining a closed ring (Figure 6) and comprising one or more flexible portions (Figure 7 near items 12, 14; [0020]), wherein the core is capable of deformation about the flexible portion between a first configuration and a second configuration upon application of a predetermined force (The applicant is advised that, while the features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function. In addition, it has been held by the courts that apparatus claims cover what a device is, not what a device does. See MPEP 2144 (I). In this case, the patented apparatus of Lim discloses (as detailed above) all the structural limitations required to perform the recited functional language, therefore was considered to anticipate the claimed apparatus. See, for example [0003] which teaches how the difference in ring flexibilities allows deformation ([0022])), and wherein the flexible portions comprise polymer and at least one portion that is without metal ([0020] elastomeric portions – elastomeric material is considered to be “without metal”), and sections of the closed ring exclusive of the flexible portions comprise metal ([0030] the ring includes wires 30a-b made of nitinol);
but is silent with regards to there being a resilient intermediate layer and a fabric cover layer.
However, regarding claim 1 Brunnett teaches annuloplasty rings can include a core ([0037] inner core 42), resilient intermediate layer ([0039] elastomeric sleeve 44), and fabric cover ([0039] fabric covering 46). Lim and Brunnett are involved in the same field of endeavor, namely annuloplasty rings. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the ring of Lim to include an intermediate resilient layer such as is taught by Brunnett in order to provide the ring with bulk to ease handling of the implant and allow passage of sutures therethrough ([0005]).
Regarding claim 2 the Lim Brunnett Combination teaches the ring of claim 1 substantially as is claimed,
wherein Lim further discloses the flexible portions of the core comprise polymer ([0020] silicone).
Regarding claim 4 the Lim Brunnett Combination teaches the ring of claim 1 substantially as is claimed,
wherein Lim further discloses the core comprises a plurality of metal wires (Figure 7 items 30a-b).
Regarding claim 5 the Lim Brunnett Combination teaches the ring of claim 4 substantially as is claimed,
wherein Lim further discloses the wires are fabricated of Elgiloy or Nitinol ([0030]).
Regarding claim 6 the Lim Brunnett Combination teaches the ring of claim 1 substantially as is claimed,
but is silent with regards to the core comprising titanium.
However, regarding claim 6 Lim teaches an embodiment in which the core comprises titanium ([0029]), and Burnett also teaches wherein annuloplasty ring cores can comprise titanium ([0037]). It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the core material of Lim’s wires 30a-b so they are made of titanium as a known alternative in the art (see [0029] nitinol and titanium are known alternative materials).
Regarding claim 7 the Lim Brunnett Combination teaches the ring of claim 1 substantially as is claimed,
wherein Brunnett further teaches the core comprises PEEK ([0037]).
Regarding claim 8 the Lim Brunnett Combination teaches the ring of claim 1 substantially as is claimed,
wherein Brunnett further teaches the intermediate layer comprises polymer or rubber ([0039]).
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 extension fee 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 Jacqueline Woznicki whose telephone number is (571)270-5603. The examiner can normally be reached M-Th 10am-6pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jerrah Edwards can be reached on 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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/Jacqueline Woznicki/Primary Examiner, Art Unit 3774 11/04/25