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 .
Claim Interpretation
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
No claim limitation has been interpreted under 35 U.S.C. 112(f) because each term (e.g., ‘expandable foam’) connotes sufficient structure to a POSITA. See MPEP § 2181. If applicant contends otherwise, please point to supporting disclosure.”
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 6, 9, 11 and 17-20 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 6 recites the limitation "the proximal covering" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 9 recites the limitation "the proximal covering" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 11 recites the limitation "the tubular support" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 17 recites the limitation "insert" in line 4. There is insufficient antecedent basis for this limitation in the claim.
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.
Claim(s) 1-3, 5, 7, and 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kaplan et al. (US 2014/0277074A1, “Kaplan”) in view of Oberti et al. (US 2009/0177262A1, “Oberti”).
Regarding claim 1, Kaplan discloses a left appendage closure (LAAC) device capable of occluding the left atrial appendage (LAA). The device includes an implant capable of trans-septal delivery to the LAA and includes an expandable foam (1204; Fig. 2; [0009, 0045]). A covering in the form of a catheter (900;[0013, 0062]) is disposed over the implant and is capable of protecting the implant during trans-septal delivery to the LAA and removal after trans-septal delivery to the LAA. However, Kaplan does not disclose that that the covering is formed of polymer.
In the same field of endeavor, LAA treatment, Oberti teaches a catheter (84; [0111]) that is passed over a guidewire (80) and a pushrod (92; [0112]) that is used to advance an implant (12) out of the catheter to the LAA. The catheter disposed over the implant during delivery and is formed of polymeric material, e.g., silicone, PTFE, ePTFE, plastic polymer [0111]. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have formed the material of the catheter of Kaplan of polymeric material, as taught by Oberti, to provide the catheter with a flexible, resiliently yieldable material [0111].
Regarding claims 2, the combination of Kaplan and Oberti discloses a foam implant (2500; [0081]; Kaplan) that includes an implant lumen extending therethrough prior to expansion (Fig. 25A). A tubular support rod (2506) extends through the implant lumen and is operably coupled with at least a portion of the covering (2504). The tubular support rod defines a tubular support rod lumen through which a lead (2502) is capable of extending (Fig. 25A; Kaplan). The tubular support rod lumen is capable of accommodating one or more of a guidewire or a radio frequency (RF) energy wire. It is noted that the guidewire and radio frequency energy wire are not positively recited.
Regarding claim 3, the combination of Kaplan and Oberti discloses that the implant has a shape that facilitates trans-septal delivery to the LAA (Fig. 2; Kaplan).
Regarding claim 5, the combination of Kaplan and Oberti discloses that the implant includes expandable foam that expands upon exposure to moisture [0072; Kaplan].
Regarding claim 7, the combination of Kaplan and Oberti discloses that the polymeric covering and tubular support rod are capable of being independently pulled proximally to expose the implant (Fig. 25A; Kaplan).
Regarding claim 10, the combination of Kaplan and Oberti discloses one or more anchor features (barbs; 2302) are embedded within the implant for anchoring the LAAC device within the LAA [0056, 0073].
Claim(s) 4, 10 and 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kaplan et al. (US 2014/0277074A1, “Kaplan”) in view of Oberti et al. (US 2009/0177262A1, “Oberti”), as applied to claim 1 above, and further in view of Meyer et al. (US 2015/0196305A1, “Meyer”).
Regarding claims 4, 10 and 12, the combination of Kaplan and Oberti does not disclose that the implant is expandable foam that expands upon reaching a temperature elevated from ambient temperature.
In the same field of endeavor, devices for LAA treatment, Meyer teaches a temperature activated memory shape foam [abs, 0027, 0034-0045, 0050-0052], wherein the foam is capable of expanding upon reaching a temperature elevated from ambient temperature [0036, 0040, 0041] and is formed of shape memory foam. The foam includes anchoring mechanism (16) in the form of hooks [0044; Fig. 5]. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the material of the implant of the combination of Kaplan and Oberti, with a temperature activated shape memory foam, taught by Meyer, as this modification involves the simple substitution of one expandable foam for another for the predictable result of creating a seal to protect against blood clots forming and escaping from left atrial appendage [0045-0046, 0050]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have formed the implant of the combination of Kaplan and Oberti, with anchor features, taught by Meyer, such that any potential for incidence of effusion is reduced or eliminated.
Allowable Subject Matter
Claims 8 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Claims 13-16 are allowed. The prior art does not disclose or suggest a left atrial closure device including a cone-shaped covering disposed over an expandable foam cone-shaped implant, the cone-shaped covering including a distal region having a plurality of perforations adapted to split apart to facilitate removal of the cone-shaped covering, an insert lumen extending through the cone-shaped implant when in its delivery configuration, a tubular support rod operably coupled to at least a portion of the cone-shaped covering, in combination with the other claimed limitations.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Miles et al. (US 2009/0112249A1) discloses a foam implant (302) disposed within a covering (310; Fig. 16).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOCELIN C TANNER whose telephone number is (571)270-5202. The examiner can normally be reached M-F 8am-4pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jackie Ho can be reached at (571)272-4696. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JOCELIN C TANNER/Primary Examiner, Art Unit 3771
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