Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on November 24th 2025 has been entered.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 120 as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994)
The disclosure of the prior-filed applications, Application No. 10/804993 and 11/473971, fail to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. The prior filed applications fail to disclose a waist portion having the features recited in lines 13-18 of claim 1, or lines 13-16 and 19-22 of claim 15. These limitations appear to be supported by the disclosure of Figure 13e in Application 11/820841. Therefore, June 21st 2007 (the filing date of Application 11/820841) is the earliest date to which claim 1 and its dependents are being given priority.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under pre-AIA 35 U.S.C. 103(a) 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 non-obviousness.
Claims 1-14 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Meng (US 2008/0033478) in view of Freudenthal (US 2008/0262518) and Amplatz et al. (US 2005/0228434).
Regarding claim 1, Meng discloses a collapsible (Figure 1A; ¶[0004]) medical device (100) comprising: an expanded preset configuration (Figure 1C; ¶[0005]) with: a first expanded diameter portion (120a); a second expanded diameter portion (120b) ; and a waist portion (124) coupling the first expanded diameter portion to the second expanded diameter portion, the waist portion having (i) a first outer edge portion (vertical line at 124 in Figure 1C; see drawing below) extending from the first expanded diameter portion to the second expanded diameter portion along a first side of the waist portion, and (ii) a second outer edge portion (the opposite vertical line defining section 124; see drawing below) extending from the first expanded diameter portion to the second expanded diameter portion along a second, opposing side of the waist portion and wherein a diameter of the waist portion varies along a length thereof (see tapering diameter at ends of the waist portion below), when the medical device waist portion is unconstrained in the expanded preset configuration of the medical device.
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[AltContent: textbox (Waist Portion)][AltContent: textbox (Second Outer Edge Portion)][AltContent: textbox (First Outer Edge Portion)][AltContent: connector][AltContent: connector][AltContent: arrow][AltContent: arrow]
Meng is silent as to whether or not the cross-sectional shape of the waist is symmetric or not and therefore fails to disclose that a radius of curvature of the first outer edge portion at an interface between the first outer edge portion and the first expanded diameter portion differs from a radius of curvature of the second outer edge portion at an interface between the second outer edge portion and the second expanded diameter portion, when the waist portion is constrained in the expanded preset configuration of the medical device.
Freudenthal teaches providing a waist portion (15) with an irregular, asymmetric shape in order to better conform to an opening (¶[0121], [0122]; Figure 63; also see page 37, lines 12-14 and Figure 63 of provisional application 60/853,128) such as in an atrial septal defect (¶[0037]; [0055]; see page 14, line 15 and page 21, lines 3-6 of provisional application 60/853,128).
It would have been obvious to one of ordinary skill in the art at the time of Applicant’s invention and in view of Freudenthal to have provided the waist portion of Meng with an irregular, asymmetric cross-sectional shape (such as in Figure 63 of Freudenthal) in order to better conform to an opening. With this modification, the outer edges would have a different radius of curvature at the interfaces as claimed.
Meng fails to disclose an outer and inner metal fabric layer as claimed. Meng discloses that the device is intended to occlude septal defects of the heart (¶[0005], [0007]).
Amplatz ‘434 discloses a similar device (e.g. Figure 3) for occluding abnormal body openings which is formed of outer and inner metal fabric layers formed of respective first and second pluralities of strands in order to more rapidly occlude the openings (Abstract).
It would have been obvious to one of ordinary skill in the art at the time of Applicant’s invention to have formed the device of Meng from the outer and inner metal fabric layers of Amplatz et al. in order to more rapidly occlude abnormal body openings.
Regarding claim 2, a diameter of the metal strands of the second plurality of braided metal strands is less than a diameter of the metal strands of the first plurality of braided metal strands (¶[0052] of Amplatz).
Regarding claim 3, the diameter of metal strands of the first plurality of braided metal strands is in a range from 0.0015 inches to 0.0035 inches (¶[0052] of Amplatz).
Regarding claim 4, the diameter of metal strands of the second plurality of braided metal strands is in a range from 0.001 inches to 0.002 inches (¶[0052] of Amplatz).
Regarding claim 5, the number of braided metal strands of the first plurality of braided metal strands is 144 (¶[0018] of Amplatz).
Regarding claim 6, the number of braided metal strands of the second plurality of braided metal strands is 144 (¶[0018] of Amplatz).
Regarding claims 7 and 8, a first clamp (120 of Amplatz) would couple together proximal ends of the inner and outer metal fabric layers, the first clamp defining an internally threaded bore (122) for receiving a distal end of a delivery device.
Regarding claim 9, Applicant has not disclosed any advantage for having external threads over internal thread on the clamps. Therefore, it would have been obvious to one having ordinary skill in the art at the time the invention was made to have provided external threads on the first clamp since it has been held that a mere reversal of the essential working parts of a device involves only routine skill in the art. In re Einstein, 8 USPQ 167.
Regarding claim 10, a second clamp (120 Amplatz) would couple together distal ends of the inner and outer metal fabric layers.
Regarding claim 11, it would have been obvious to one of ordinary skill in the art at the time of Applicant’s invention to have provided the inner and outer fabric layers with the same shape since Amplatz does not disclose any difference in their shapes and it is apparent that the layers lying in close opposition creates the enhanced braid density which more rapidly occludes blood.
Regarding claim 12, in the expanded preset configuration, the first and second expanded diameter portions have a crescent shape (as seen in side view of Meng, Figure 1C).
Regarding claim 13, in the expanded preset configuration, the first and second expanded diameter portions have a circular shape (as seen in end view of Meng, Figure 1C).
Regarding claim 14, providing the expanded diameter sections with an ovular shape would be an obvious matter of design choice for one skilled in the art since Applicant has not disclosed that the claimed ovular shape solves any stated problem or is anything more than one of numerous shapes or configurations a person ordinary skill in the art would find obvious for the purpose of providing an enlarged expanded section for anchoring the device within tissue. In re Dailey and Eilers, 149 USPQ 47 (1966).
Allowable Subject Matter
Claims 15-20 are allowed.
Response to Arguments
Applicant’s arguments with respect to the pending claims have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Thomas McEvoy whose telephone number is (571) 270-5034 and direct fax number is (571) 270-6034. The examiner can normally be reached on Monday-Friday, 9:00 am – 6:00 pm.
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/THOMAS MCEVOY/Primary Examiner, Art Unit 3771