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 12/18/25 have been fully considered but they are not persuasive.
On pages 12-13 Applicant argues amendments overcome the rejection of record, since Aklog describes “struts, crossbars, or restraining members” ([0078]), and argues that the ordinary meaning a strut would resist pressure in the direction of its length, which is inconsistent with the broadest reasonable interpretation of a filament which buckles under a compressive load applied along its length.
The Examiner respectfully disagrees. First, Aklog describes “struts, crossbars or restraining members” ([0078]), which covers more than just a “strut” as Applicant is arguing. Further, while Applicant refers to filaments being unable to resist pressure along their length direction, the Examiner does not find evidence of this in the definition of a filament, and also notes this argument fails to take into account that the barrier members of Aklog might be “crossbars” or “restraining members” as opposed to struts. The Examiner understands the term “filament” to be “a single thread of a thin flexible threadlike object, process, or appendage” (Merriam-Webster), which does not include any mention or requirement of compressive loads applied along a length as Applicant argues. Any thin flexible thin threadlike object, regardless of its ability to handle pressure in any dimension/along any direction, is understood to meet the definition of a “filament”. The Examiner notes no special definition of “filament” provided by the Applicant in their specification. The Examiner notes the restraining members of the barrier are described as being flexible ([0117]-[0118]), and are seen throughout to be thin and threadlike, and so meet the definition of a “filament”.
Further, on page 13 Applicant argues that Aklog’s structures are “individual struts or members” and are not “filaments that are interwoven to form a mesh” even though Aklog describes “net-like” structures.
The Examiner respectfully disagrees, pointing out again that while Applicant has narrowed in on Aklog indicating their members can be “struts or crossbars”, they are also described as being “restraining members”. The restraining members pictured by Aklog are understood to be thin and thread-like and are described as being flexible ([0017]-[0118]), and accordingly meet the broadest reasonable definition of a “filament”. As regards them not being interwoven, the Examiner points out that the filaments being “interwoven” is part of the definition of a net, making this argument unpersuasive. (Merriam-Webster defines “net” as “an open-meshed fabric twisted, knotted, or woven together at regular intervals”.)
On page 13 Applicant argues element 80 in figure 3b of Aklog is a “primary cross-restraint” and elements 82 are “secondary restraints”, meaning the description of Aklog [0077] that states the secondary restrains can be wrapped around the cross-restraint does not teach filaments which are interwoven with one another for form a mesh. Applicant concludes the primary cross-restraint 80 is a “distinct structural element” from the secondary restraints, and the primary cross-restraint is not a filament forming a mesh with the other filaments.
The Examiner respectfully disagrees and notes no part of the claim requires all the filaments to be identically shaped or directed. Simply because Aklog describes some filaments as “primary” and others as “secondary”, it does not appear to affect the understanding that these elements are still filaments (e.g. thin, flexible, threadlike).
Drawings
The drawings are objected to because the specification uses item 28 to represent both “markers” and “mitral valve”.
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. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. 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 § 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 1-3, 5-10, 12, 15, 18, 20, 27-29, 49 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shaoulain et al. (US 20050288783 A1) hereinafter known as Shaoulain in view of Aklog et al. (US 20050004668 A1) hereinafter known as Aklog.
Regarding claim 1 Shaoulain discloses an atrioventricular valve repair ring ([0008] mitral, tricuspid valve) comprising a ring comprising:
a core ([0008] core; Figure 20a item 2012) having a first peripheral shape (Figure 20a) comprising an arcuate shape that circumscribes an inner volume of the ring (Figure 20a; [0069] the ring can be circular and closed in shape so the ring circumscribes the inner volume);
a sheath surrounding at least a portion of the core ([0170] suturable material);
wherein the core is configured to spontaneously change from the first peripheral shape to a second peripheral shape when arranged within a heart of a subject in response to a change in temperature of the core (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 Shaoulain 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 [0172], [0010] in response to heat, the shape memory material changes the shape of the ring.),
but is silent with regards to there being a barrier coupled to the sheath and spanning the inner volume of the ring configured to permit blood flow therethrough while preventing valve leaflets from passing beyond the barrier,
and the barrier comprising a plurality of filaments that are interwoven to forma mesh, the filaments being coupled to the sheath by stitching to the sheath.
However, regarding claim 1 Aklog discloses an atrioventricular valve repair ring ([0035] mitral valve) comprising a ring comprising a barrier (Abstract: restraining structure) which is coupled to the surrounding ring so the barrier spans the inner volume of the ring (Figures 2a, 3a-d, 4a-d, 5a-d, etc.) which is configured to permit blood flow therethrough while preventing valve leaflets from passing beyond the barrier (Abstract; [0078]; [0081], [0096], etc.),
wherein the barrier comprises a plurality of filaments ([0078] net-like restraining structure, see figures 2+ which show many thin, flexible thread-like objects) which are interwoven to form a mesh ([0078] a net-like restraining structure (net is defined by Merriam-Websters as “an open-meshed fabric twisted, knotted, or woven together at regular intervals”. Aklog Figure 3b shows filaments 80 and filaments 82 which are interwoven with one another. Alternatively, while Aklog does not discuss whether or not the members are interwoven, they do describe their restraining structure as being “net-like” ([0078]). Since a “net” is defined as having its elements “twisted, knotted, or woven together at regular intervals”, the person of ordinary skill in the art at the time the invention was filed would have alternatively found it obvious to ensure the net-like restraining structure was interwoven.),
and wherein Aklog further teaches barrier member elements can be coupled to the sheath by stitching the filaments to the sheath ([0108] the barrier members can be fixed to the ring by knot tying (Fig 17b3)).
Shaoulain and Aklog 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 Shaoulain to include a barrier mesh made of interwoven filaments and secured to the sheath by stitching as is taught by Aklog in order to enable the ring to function as a single device which only requires a simple procedure to repair a valve which not only remodels a defective valve annulus, but also corrects other problems such as leaflet prolapse which prevents ancillary procedures ([0025]).
Regarding claim 2 the Shaoulain Aklog Combination teaches the ring of claim 1 substantially as is claimed,
wherein Shaoulain further discloses the core has an annular shape and defines a continuous periphery of the ring ([0008] the ring can be a closed ring and circular, C-shaped, or D-shaped).
Regarding claim 3 the Shaoulain Aklog Combination teaches the ring of claim 2 substantially as is claimed,
wherein Shaoulain further discloses the core has an elliptical annular shape ([0171] elliptical tube shape).
Regarding claim 5 the Shaoulain Aklog Combination teaches the ring of claim 1 substantially as is claimed,
wherein Shaoulain further discloses the core is composed of a shape-memory material ([0171] shape memory tube 2012).
Regarding claim 6 the Shaoulain Aklog Combination teaches the ring of claim 5 substantially as is claimed,
wherein Shaoulain further discloses the core is composed of a shape-memory alloy ([0171]).
Regarding claim 7 the Shaoulain Aklog Combination teaches the ring of claim 6 substantially as is claimed,
wherein Shaoulain further discloses the core is composed of nitinol ([0086]).
Regarding claim 8 the Shaoulain Aklog Combination teaches the ring of claim 5 substantially as is claimed,
wherein Shaoulain further discloses the core is formed of a shape-memory polymer ([0171]).
Regarding claim 9 the Shaoulain Aklog Combination teaches the ring of claim 1 substantially as is claimed,
wherein Shaoulain further discloses the sheath is composed of a textile material ([0170] woven cloth).
Regarding claim 10 the Shaoulain Aklog Combination teaches the ring of claim 9 substantially as is claimed,
wherein Shaoulain further discloses the textile material is a polymer-based textile material ([0170] woven polyester cloth).
Regarding claim 12 the Shaoulain Aklog Combination teaches the ring of claim 1 substantially as is claimed,
wherein Shaoulain further discloses the sheath fully encloses the core ([0099] the suturable material may be disposed about the entire circumference of the tubular member 112).
Regarding claim 15 the Shaoulain Aklog Combination teaches the ring of claim 14 substantially as is claimed,
wherein Shaoulain further teaches some of the filaments are looped around others when forming the mesh (see for example Figure 3b in which filament82 is looped around filament 80).
Regarding claim 18 the Shaoulain Aklog Combination teaches the ring of claim 13 substantially as is claimed,
wherein Aklog further teaches the filaments are asymmetrically distributed within the inner volume of the ring such that some portions of the barrier have a higher density of filaments than other portions of the barrier (see for example, Figures 2a, 3a-c, 4a, 4c-d, 5d, etc.).
Regarding claim 20 the Shaoulain Aklog Combination teaches the ring of claim 13 substantially as is claimed,
wherein Aklog further teaches the filaments are composed of ePTFE ([0096]).
Regarding claim 27 the Shaoulain Aklog Combination teaches the ring of claim 1 substantially as is claimed,
wherein Shaoulain further discloses at least one marker coupled to the ring ([0010] imaging marker of radiopaque material; see also [0166] where multiple markers are seen for marking commissures) to facilitate placement of the ring during a surgical procedure (this is stated as a functional limitation (See the explanation in the rejection to claim 1 above). See also [0166] markers can be imaged in vivo).
Regarding claim 28 the Shaoulain Aklog Combination teaches the ring of claim 27 substantially as is claimed,
wherein Shaoulain further discloses the marker is composed of a radiopaque material ([0010]).
Regarding claim 29 the Shaoulain Aklog Combination teaches the ring of claim 27 substantially as is claimed,
wherein Shaoulain further discloses a plurality of markers ([0010] imaging marker of radiopaque material; “at least one” metallic wire; see also [0166] where multiple markers are seen for marking commissures) distributed about an outer surface of the sheath ([0010] the thermally conductive marker can be placed over the suturable material).
Regarding claim 49 the Shaoulain Aklog Combination teaches the ring of claim 1 substantially as is claimed,
wherein Shaoulain further discloses the change of temperature is an increase in temperature ([0010] the change in shape occurs in response to heat).
Claim 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shaoulain and Aklog as is applied above, further in view of Marquez (US 20030040793 A1).
Regarding claim 11 the Shaoulain Aklog Combination teaches the ring of claim 10 substantially as is claimed,
wherein Shaoulain further discloses the material is PTFE ([0170]),
but is silent with regards to the PTFE being expanded.
However, regarding claim 11 Marquez teaches that annuloplasty ring sheaths can be made of an ePTFE textile ([0029]). Shaoulain and Marquez 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 the Shaoulain Aklog Combination by having the sheath be ePTFE as is taught by Marquez it has been held by the courts that selection of a prior art material on the basis of its suitability for its intended purpose is within the level of ordinary skill. See MPEP 2144.07.
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.
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 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.
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.
/Jacqueline Woznicki/Primary Examiner, Art Unit 3774 01/05/25