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 .
Benefit
The application claims benefit as a National Stage entry under 35 USC 371 from PCT/US2023/018438 (13 April 2023) which claims benefit of US Provisional 63/331,836 (17 April 2022).
Election/Restrictions
Applicant’s election without traverse of Group II (claims 15-20) without traverse in the reply filed on 22 April 2026 is acknowledged.
Formal Matters
Claims 1-20 are pending. Claims 1-14 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 22 April 2026. Claims 15-20 are under examination.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 16 January 2025, 21 April 2025, 17 July 2025, and 8 January 2026 have been considered by the examiner. Signed copies are attached.
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.
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.
Claims 15-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Mendez et al., Castellano et al., US 20120271340 (25 October 2012).
Regarding independent claim 15, Castellano teaches a filter assembly (FIG 7, filter 80) comprising:
an elongate support element (FIG 8, annular ring 82; ¶¶51, 53) having a distal end configured to be advanced through a patient's vena cava (inferior vena cava 24, ¶59) through the patient's heart atrium (right atrium 40, left atrium 42; ¶59) into the patient's heart ventricle (¶59);
a filter (80) comprising a foraminous basket (mesh 84; ¶51) having an open end secured to the distal end of the elongate support element (FIGs 7-8);
wherein the foraminous basket (mesh 84, ¶51) is configured to be placed in or over a ventricular heart valve (FIG 6, mitral valve annulus 48, ¶51; tricuspid valve, ¶59) which establishes blood flow from the heart ventricle into the patient's vasculature (¶¶51, 59);
wherein emboli released into the ventricle while treating an atrial heart valve is captured by the filter (80) during ventricular systole when blood flows from the ventricle through the filter into the patient’s vasculature (¶¶51, 59).
Regarding claim 16, Castellano teaches the filter assembly of claim 15, as set forth above, wherein the filter (80) is configured to be placed over a ventricular side of the ventricular heart valve (¶59).
Regarding claim 17, Castellano teaches the filter assembly of claim 16, as set forth above, wherein the filter (80) is further configured to cover a portion of a wall of the ventricle surrounding the ventricular heart valve (¶59).
Regarding claim 18, Castellano teaches the filter assembly of claim 16, as set forth above, wherein the filter (80) is configured to be placed into a root of the ventricular heart valve (FIG 6; ¶51).
Regarding claim 19, teaches the filter assembly of claim 15, as set forth above, wherein the open end is configured to be closed to secure emboli therein prior to removal from the patient (¶60).
Regarding claim 20, Castellano teaches the filter assembly of claim 19, as set forth above, wherein the filter (80) further comprises a cinching loop (tethers 90, 92; ¶53) circumscribing the open end of the filter (80).
Conclusion
No claim is allowed.
The prior art made of record and not presently relied upon is considered pertinent to applicant's disclosure:
Mendez et al., WO 2019089821 (9 May 2019) teaches embolic protection devices and methods of embolic protection (cited on Applicant’s IDS of 16 January 2025).
Hill et al., US 20120271341 (25 October 2012) teaches method and apparatus for treating a mitral valve prolapse and providing embolic protection (cited on Applicant’s IDS of 16 January 2025).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHERIE M POLAND whose telephone number is (703)756-1341. The examiner can normally be reached M-F 9am-6pm (CST).
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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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/CHERIE M POLAND/Examiner, Art Unit 3771
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