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 . Claims 1-20 are pending and examined below.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference character “116” has been used to designate both two different parts in figure 19. Corrected drawing sheets in compliance with 37 CFR 1.121(d) 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.
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: Reference characters 112 and 114 in figures 17, & 19-20. 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 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) 1-20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lucatero et al. (US 7226467 B2) hereinafter, Lucatero.
Regarding claim 1, Lucatero teaches
a fixation device (14, Fig. 9) for fixation of tissue comprising:
a central assembly (74, Fig. 18);
first (18, Fig. 18) and second arms (another of 18, Fig. 18) coupled to the central assembly (74, Fig. 18) and being moveable relative thereto between an open position (Fig. 11B) and a closed position (Fig. 10B),
the first and second arms being asymmetrically configured such that when the first and second arms are in the closed position, the second arm is at least partially received within the first arm (received at hinged area, see annotated Fig. 10B);
a first gripping element (16, Fig. 18) disposed opposite the first arm (18, Fig. 18) and moveable relative to the first arm to capture a first tissue therebetween (Figs. 3A, 11B, & 13B); and
a second gripping element (another of 16, Fig. 11B) disposed opposite the second arm (another of 18, Fig. 11B) and moveable relative to the second arm to capture a second tissue therebetween (Figs. 3A, 11B, & 13B).
Regarding claim 2, Lucatero teaches
wherein the first arm (18, Fig. 18) includes a body portion having first and second body lateral sides (see annotated Fig. 18 below) and first and second wing extensions extending from the respective first and second body lateral sides (see annotated Fig. 18 below).
Regarding claim 3, Lucatero teaches
wherein the first and second wing extensions are nondeformable wing extensions integrally formed with the body portion (see annotated Fig. 18 below).
Regarding claim 4, Lucatero teaches
wherein the first arm includes a first end, a second end, and a longitudinal axis extending therebetween, and the first and second wing extensions extend between the first and second end (see annotated Fig. 18 below).
Regarding claim 5, Lucatero teaches
wherein the first and second wing extensions extend from the body portion toward the second arm when in the closed position (see annotated Fig. 18 below).
Regarding claim 6, Lucatero teaches
wherein the first and second wing extensions extend perpendicular to the body portion (see annotated Fig. 18 below).
Regarding claim 7, Lucatero teaches
wherein the first and second wing extensions each have an outer lateral edge bent toward the lateral outer edge of the other wing extension (see annotated Fig. 18 below).
Regarding claim 8, Lucatero teaches
wherein the first and second wing extensions each have an outer lateral edge defining a maximum arm width of the first arm which is wider than a maximum arm width of the second arm (see annotated Fig. 18 below).
Regarding claim 9, Lucatero teaches
wherein the first and second gripping elements (16 & another of 16, Fig. 16) are disposed between the first and second arms (18 and another of 18, Fig. 16) when the first and second arms are in the closed position (Fig. 16).
Regarding claim 10, Lucatero teaches
wherein the first and second gripping elements (16 & another of 16, Fig. 11B) each include a plurality of frictional elements (60, Fig. 11B) extending therefrom for engagement with the respective first and second tissues (gripping of the leaflets, col. 25 line 26).
Regarding claim 11, Lucatero teaches
wherein the central assembly (74, Fig. 16) is disposed between the first and second arms (18 and another of 18, Fig. 16) when the first and second arms are in the closed position (Fig. 16).
Regarding claim 12, Lucatero teaches
wherein the central assembly (74, Fig. 16) includes a coupling member (19, Fig. 16) configured to be releasably coupled to a delivery catheter (86, Fig. 15).
Regarding claim 13, Lucatero teaches
a fixation device (14, Fig. 9) for fixation of tissue comprising:
a central assembly (74, Fig. 18);
first and second arms (18 and another of 18, Fig. 18) coupled to the central assembly (74, Fig. 18) and being moveable relative thereto between an open position (Fig. 11B) and a closed position (Fig. 10B),
the first arm being configured to surround the second arm on at least three sides when the first and second arms are in the closed position (Fig. 10B);
a first gripping element (16, Fig. 18) disposed opposite the first arm (18, Fig. 18) and moveable relative to the first arm to capture a first tissue therebetween (Figs. 3A, 11B, & 13B); and
a second gripping element (another of 16, Fig. 11B) disposed opposite the second arm (another of 18, Fig. 11B) and moveable relative to the second arm to capture a second tissue therebetween (Figs. 3A, 11B, & 13B).
The phrase “…configured to surround the second arm on at least three sides when the first and second arms are in the closed position” is a functional recitation that is not given full patentable weight. The implant is not positively recited here, but is instead merely recited as part of the intended use of the implantation device. Therefore, the prior art is not required to explicitly disclose the particular features of the implant, but merely have the capability of being used to deliver such an implant in order to meet the claim requirements. In this case, the Lucatero device discloses all the claimed structural features and is considered to be capable of surrounding the second arm on at least three sides when the first and second arms are in the closed position.
Regarding claim 14, Lucatero teaches
wherein the first arm includes a body portion having first and second body lateral sides and first and second wing extensions extending from the respective first and second body lateral sides, the first and second wing extensions being positioned at first and second sides of the second arm when the first and second arms are in the closed position (see annotated Fig. 18 below).
Regarding claim 15, Lucatero teaches
wherein the body portion and first and second wing extensions define a recess within which the second arm is received when in the closed position (see annotated Fig. 18 below).
Regarding claim 16, Lucatero teaches
wherein the recess is a U-shaped recess in a cross-section transverse to a longitudinal axis of the first arm (see annotated Fig. 18 below).
Regarding claim 17, Lucatero teaches
wherein the first and second arms each include a fixed end coupled to the central assembly (74, Fig. 18) and a free end disposed opposite the fixed end (see annotated Fig. 18 below),
the free ends of the first and second arms being positioned further from each other when in the open position than in the closed position (see annotated Fig. 18 below).
Regarding claim 18, Lucatero teaches
wherein the central assembly (74, Fig. 18) includes a locking mechanism (106, Fig. 18) configured to secure the first and second arms in the closed position (col. 27 lines 26-28).
Regarding claim 19, Lucatero teaches
a fixation device (14, Fig. 9) for fixation of tissue comprising:
a central assembly (74, Fig. 18);
a first arm (18, Fig. 18) moveably coupled to the central assembly (74, Fig. 18) and having a body portion and first and second wing extensions extending from the body portion (see annotated Fig. 18 below),
the first and second wing extensions at least partially defining a recess having a first width (see annotated Fig. 18 below);
a second arm moveably coupled to the central assembly and defining a second width smaller than the first width such that the second arm is receivable within the recess of the first arm between the first and second wing extensions (see annotated Fig. 18 below); and
a first gripping element (16, Fig. 18) disposed opposite the first arm and moveable relative to the first arm to capture a first tissue therebetween (Figs. 3A, 11B, & 13B); and
a second gripping element (another of 16, Fig. 11B) disposed opposite the second arm and moveable relative to the second arm to capture a second tissue therebetween (Figs. 3A, 11B, & 13B).
Regarding claim 20, Lucatero teaches
wherein the first and second arms are moveable between an open position and a closed position (Figs. 10B & 11B), and
when the first and second arms (18 and another 18, Fig. 10B) are in the closed position, the central assembly (74, Fig. 10B), first and second gripping elements (16 and another of 16, Fig. 10B), and second arm are each disposed within the recess of the first arm (since one of the 18 is located inside of the hinged area, therefore it would make this second 18 smaller in width to fit within the recess of the first 18, see annotated Fig. 10B).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1, 13, & 19 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 15, 18, & 19 of U.S. Patent No. US 12178704 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because subject matter in the claims of the present application match claims in the patent according to the following table.
Claims of U.S. Pat. App. No. 18/956,214
Claims of U.S. Patent No. US 12178704 B2
1
1, 15, 18, 19
13
1, 15, 18, 19
19
1, 15, 18, 19
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477
729
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442
347
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Greyscale
Conclusion
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/K.X.W./Examiner, Art Unit 3774
/JERRAH EDWARDS/Supervisory Patent Examiner, Art Unit 3774
