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 Amendment
The amendment filed 09/11/2025 has been entered. Claims 1-5 and 8-9 remain pending in the application, and claims 5-6 are cancelled. Applicant’s amendments to the claims have overcome each 112(b) rejection and the interpretation of the prior art rejection previously set forth in the Non-Final Office Action mailed 05/14/2025, however a new rejection of Kapadia in view of Kreidler is applied as outlined below.
Response to Arguments
Applicant’s arguments with respect to claims have been considered but are moot because the new ground of rejection does not rely on the previous interpretation of the reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. Arguments directed to the claims as amended are addressed in the body of the rejection below.
Claim Rejections - 35 USC § 103
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 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.
Claims 1-5 and 8-9 are rejected under 35 U.S.C. 103 as being unpatentable over Kapadia et al. (US PGPub 2007/0156233), hereinafter known as “Kapadia,” in view of Kreidler (US PGPub 2007/0066993).
With regards to claim 1, Kapadia discloses (Figures 1-13) a left atrial auricle occluder 10 configured to be implanted into a left atrium 16 through a transcatheter route to plug and seal an opening 52 to the left auricle (figures 7-13; paragraphs 10 and 50), the occluder 10 comprising:
a self-expandable hyperelastic cage 62 (paragraphs 49-50 – peelable catheter 88 is removed and occluder 10 progressively expands; paragraph 35 – Nitinol material – Nitinol is a superelastic alloy; paragraph 33 – cage-like structure) configured to occupy substantially all of the left atrium 16 resting against an inner surface of the left atrium 16 (figures 5 and 13) and provided with an anchoring portion 58 configured to be retained frontally against a rim of the opening 52 to the left auricle, plugging the opening 52 to the left auricle by an elastic thrust exerted by said cage 62 (paragraphs 49-50 – cage 62 is elastic and expanded at the same time as the anchoring portion 58, thus causing the anchoring portion 58 to be retained frontally and plugged against a rim of an auricle as seen in figures 12-13).
Kapadia is silent to an end obturator configured to be retained frontally against a rim of the opening to the left auricle, plugging and hermetically sealing the opening to the left auricle.
However, in a similar field of endeavor of left atrial auricle occluders, Kreidler teaches (Figures 2 and 15L-15N) an end obturator 500B configured to be retained frontally against a rim of the opening to the left auricle 106, plugging and hermetically sealing the opening to the left auricle 106 (paragraph 60 – “A second membrane 500B is provided at the distal end of the cage 300 to create a barrier to the ingress of material, such as particles or fluid or both, into the left atrium 104 from the left atrial appendage 106”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the anchoring portion of Kapadia for the end obturator as taught by Kreidler for the purpose of creating a barrier to the ingress of material, such as particles or fluid or both, into the left atrium (paragraph 60 of Kreidler).
With regards to claim 2, as rejected above, it would be obvious to modify the anchoring portion of Kapadia for the end obturator of Kreidler. Kreidler further discloses wherein the obturator 500B has a generally conical or ogival shape (figures 15M-15N) and has a size configured to cover the rim of the opening of the left auricle 106 and beyond a perimeter of the rim of the opening of the left auricle 106 (paragraph 60; figures 2 and 15M-15N). Thus, when incorporating the end obturator of Kreidler, the claimed limitation is considered obvious.
With regards to claim 3, Kapadia further discloses wherein the cage 62, following an expansion thereof, has a generally ellipsoidal shape (figure 5 – cage 62 has a generally ellipsoidal shape).
With regards to claim 4, Kapadia further discloses wherein the cage is formed by an annular network of longitudinal wires 68 having a wavy arrangement (figure 4; paragraph 34 – “the strut members 68 are comprised of linked straight segments 70 and curved segments 72 generally arranged in an alternating pattern” – alternating pattern of straight and curved segments is interpreted as a wavy arrangement).
With regards to claim 5, Kapadia further discloses wherein crests of the wavy wires 68 are juxtaposed and they are free or mutually joined (paragraph 34; figure 4 – crests of the strut members 68 are adjacent one another and are individually joined to an adjacent strut 68 with a respective crest).
With regards to claim 8, Kapadia/Kreidler disclose wherein the cage (Kapadia: 62) is open at its an end opposite to said obturator (Kreidler: 500) (Kapadia: figure 5 see opening on opposite side of 58 where ring member 63 is).
With regards to claim 9, Kapadia further discloses wherein the cage 62 is provided with a lateral passage 61 to allow, in an implanted condition of the occluder, access to a mitral valve (paragraphs 34 and 45; figure 1).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 MOHAMMED S ADAM whose telephone number is (571)272-8981. The examiner can normally be reached 8-5.
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/MOHAMMED S ADAM/Examiner, Art Unit 3771 10/22/2025
/KATHERINE M SHI/Primary Examiner, Art Unit 3771