DETAILED ACTION
Election/Restrictions
Applicant's election with traverse of Species 2, figures 2, 5a, claims 12-19 in the reply filed on 3/9/2026 is acknowledged. The traversal is on the ground(s) that Figures 7a,b are part of elected species 2 and the claims do not recite mutually exclusive characteristics” This is not found persuasive in part and the office agrees that figures 7a,b are now including of elected species 2 and further these claims are falling into different species that recites the mutually exclusive characteristics and further because of different species that would require different feature, thus requiring different search queries. This would place a serious search burden if restriction were not required.
Claims 1-11,20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 3/9/2026.
The requirement is still deemed proper and is therefore made FINAL.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
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
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.
Claim(s) 12-19 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Vilund et al CA 2 957 442 (Canada).
Claim 12: Vilund et al disclose a prosthetic heart valve (see paragraph 20, figures 1, 16) for transcatheter delivery, comprising: a collapsible and expandable inner stent 112, see paragraph 419 comprising an atrial end and a ventricular end; a plurality of valve leaflets (see paragraph 57) supported within the inner stent; a collapsible and expandable outer frame (see claim 11 ‘442) having a lower radial strength than the inner stent for conforming to a shape of a native heart valve, wherein the outer frame surrounds at least a portion of the atrial end of the inner stent and extends towards the ventricular end of the inner stent, the outer frame comprising an atrial end having a larger dimension than that of the ventricular end of the inner stent (see fig. 67, paragraph 469); a sealing material (sealing cuff, see paragraph 271) attached to the outer frame; and a plurality of anchors (fig. 11, more securing tissue anchors, see paragraph 207) extending radially outwardly of the outer frame.
Claims 13-14: Vilund et al disclose wherein at least a portion of the
outer frame is oval shaped (see fig. 49, paragraph 236); wherein at least a portion of the outer frame is shaped to resemble a native heart annulus anatomy (see claim 32’ of Vilund).
Claims 15-17: Vilund et al disclose wherein the inner stent 112 is
cylindrical in shape as best seen in fig. 1; wherein the atrial end of the outer frame extends radially outward to seat against a floor of an atrium as best seen in fig. 16; wherein the outer frame comprises a wire mesh (see fig. 24 that teaches prosthetic heart valve with the wire mesh material).
Claims 18-19: Vilund et al disclose wherein at least one of the plurality of anchors extends towards the atrial end of the inner stent and is configured to capture a native valve leaflet between the anchor and the outer frame (see fig. 11, paragraph 207); wherein at least one of the plurality of anchors forms a loop (see paragraph 85).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to VI X NGUYEN whose telephone number is (571)272-4699. The examiner can normally be reached Monday-Friday (6:30-4:30).
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, Darwin Erezo can be reached at 571-272-4695. 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.
/VI X NGUYEN/Primary Examiner, Art Unit 3771
Prosecution Insights