DETAILED ACTION
Election/Restrictions
Applicant’s election without traverse of Group 1, claims 1-17 in the reply filed on 2/25/2026 is acknowledged.
Claims 18-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 2/25/2026.
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 Objections
Claim 1 is objected to because of the following informalities:
Claim 1, recites in part “, the first proximal element being moveable towards the first retaining distal element…” in line 5 should be “the first proximal element being moveable towards a first retaining distal element …”. Appropriate correction is required.
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) 1-5, 7-17 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Goldfarb et al U.S 2010/0022823.
Claim 1: Goldfarb et al disclose a fixation device 14 for fixation of tissue as best seen in figures 25a,b,26a,b comprising: first and second distal elements 18 each having a first end, a second end opposite the first end, and an engagement surface 50 extending therebetween; first and second proximal elements 16 respectively disposed opposite the first and second distal elements, the first proximal element 16 being moveable towards a first retaining distal element (it is noted that a fixation device 14 having a textured gripping surface 212 to assist in holding the grasped leaflets within the fixation device 14. In this embodiment, the surface 212 includes a plurality of protrusions 214 which extend outwardly at an angle. The protrusions may be comprised of any suitable material, preferably a rigid material capable of piercing into and/or through the leaflet, see paragraph 112) from a first position to a second position to capture a first tissue therebetween, and the second proximal element 16 being moveable towards the second distal element 18 from a first position to a second position for capturing a second tissue therebetween; a first rigid protrusion 214 extending from the engagement surface 50 of the first distal element toward the first proximal element and being configured to urge the first tissue into contact with the first proximal element when the first proximal element is in one of the first position and the second position thereof; and a second rigid protrusion 214 extending from the engagement surface of the second distal element toward the second proximal element and being configured to urge the second tissue into contact with the second proximal element when the second proximal element is in one of the first position and the second position thereof (see paragraph 112).
Claims 2-4: Goldfarb et al disclose wherein: the first and second proximal elements 16 each include a plurality of frictional elements (the pointed tip along area 16 or barbs 60, fig. 29 have some characteristic of frictional elements) extending therefrom, the first rigid protrusion 214 is configured to urge the first tissue into engagement with the frictional elements of the first proximal element when the first proximal element is in the first position thereof so as to form a directional trap therebetween, and the second rigid protrusion 214 is configured to urge the second tissue into engagement 50 with the frictional elements of the second proximal element when the second proximal element is in the first position thereof so as to form a directional trap therebetween. , wherein each of the first and second protrusions 214 include a domed outer surface., wherein each of the first and second protrusions 214 include a curved outer surface as best seen in fig. 25a.
Claims 5, 7-10: Goldfarb et al disclose wherein the curved outer surface of each of the first and second protrusions 214 is asymmetric in a direction extending from the first end toward the second end of the respective first and second distal elements as best seen in fig. 25a., wherein the curved outer surface of each of the first and second protrusions is asymmetric in at least one axis. , wherein the curved outer surface of each of the first and second protrusions is asymmetric in at least two axes. , wherein the curved outer surface of each of the first and second protrusions is symmetric in at least one axis. , wherein the curved outer surface of each of the first and second protrusions 214 is symmetric in at least two axes as best seen in fig. 29
Claims 11-12: Goldfarb et al disclose wherein the first protrusion 214 is incorporated into the engagement surface 50 of the first distal element 18, and the second protrusion 214 is incorporated into the engagement surface 50 of the second distal element 18; wherein the first protrusion is attached to the engagement surface of the first distal element, and the second protrusion 214 is attached to the engagement surface 50 of the second distal element 18.
Claims 13-14: Goldfarb et al disclose wherein: the first end of the first distal element is pivotally coupled to a center of the fixation device14 and the second end of the first distal element 18 is a free end moveable between an open position and a closed position, and the first end of the second distal element 18 is pivotally coupled to the center of the fixation device and the second end of the second distal element is a free end moveable between an open position and a closed position (see fig. 30, paragraph 120). , wherein: the first protrusion 214 is disposed between the first end of the first distal element and a midpoint between the first end and the second end of the first distal element, and the second protrusion 214 is disposed between the first end of the second distal element and a midpoint between the first end and the second end of the second distal element as best seen in fig. 26a.
Claims 15-17: Goldfarb et al disclose wherein: the first protrusion 214 is disposed at a midpoint between the first end and the second end of the first distal element, and the second protrusion 214 is disposed at a midpoint between the first end and the second end of the second distal element 18; wherein: the first protrusion 214 is disposed between the second end of the first distal element and a midpoint between the first end and the second end of the first distal element, and the second protrusion 214 is disposed between the second end of the second distal element and a midpoint between the first end and the second end of the second distal element; wherein the engagement surface 50 of each of the first and second distal elements 18 is a concave surface (see paragraph 70, line 7).
Allowable Subject Matter
Claim 6 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.
Claim 6: the prior arts fail to disclose or reasonably suggest the claimed including the curve outer surface of each of the first and second protrusion is asymmetric in a direction transverse to a direction extending from the first end toward the second end of the respective first and second distal elements.
Conclusion
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/VI X NGUYEN/Primary Examiner, Art Unit 3771