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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 03/06/2026 has been entered.
Claim Objections
Claim 29 is objected to because of the following informalities:
Claim 29 line 1 “wherein openings” is suggested to read “wherein the openings” for better antecedent basis.
Appropriate correction is required.
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.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “locking mechanism” in claim 26.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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 21-26 and 28 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Yellin et al. (US PGPub 2013/0226290), hereinafter known as “Yellin.”
With regards to claim 21, Yellin discloses (Figures 1A-1C and 13-14; although directed to different embodiments, paragraph 136 discloses “ FIG. 13 is a view of various anchor shapes that may be used with the disclosed trans-catheter annuloplasty rings” and paragraph 137 discloses “FIG. 14 is a view of various anchor designs that may be used with the disclosed trans-catheter annuloplasty rings”) an anchor 100 for implantation in body tissue to hold a line (paragraph 65), the anchor 100 comprising a number of hooks 104/1440 for engagement with the body tissue (paragraph 63) and having a folded position (paragraph 60 – “straight configuration in a delivery system”) and an unfolded position (paragraph 60 – “operative geometry (e.g., D-shaped or C-shaped) at a delivery site within a heart”), wherein the anchor 100 is made of an elastic material (paragraph 62 – Nitinol) such that it can be elastically deformed into the folded position by application of a constraining force (paragraph 62 - catheter), and will return to the unfolded position when no constraining force is applied (paragraph 62), and wherein the hooks 1440 are formed with openings (figure 14; 1440) along their length (paragraph 137), wherein the openings in the hooks 1440 comprise slits extending along all of the length of the hooks 1440 (paragraph 137 – “Anchor design 1440 employs a single ovoid or rounded-rectangular cutout along the length of the anchor”);
wherein the anchor 100 comprises a tubular body section from which the hooks 104/1440 extend (see tubular body section in annotated figure 13 below from where the hooks 1300-1340 extend from, akin to the hooks 104/1440); and
wherein the slits (shown in 1440) extend to ends of the hooks 104/1440 where they join into the tubular body section of the anchor 100 (paragraph 137 – “Anchor design 1440 employs a single ovoid or rounded-rectangular cutout along the length of the anchor” – the length of the anchor is interpreted as the full length of the hook, the hooks shown in figure 13 extend from a tubular body section which is interpreted as part of the anchor, thus the slits extend to and beyond the ends of the hooks 104/1440 where they join into the tubular body section of the anchor; see annotated figure 13 below).
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With regards to claim 22, Yellin discloses wherein the slits (shown in 1440) extend beyond the ends of the hooks 1440 where they join into the tubular body section of the anchor 100 (see annotated figure 13 above; paragraph 137 – “Anchor design 1440 employs a single ovoid or rounded-rectangular cutout along the length of the anchor” – the length of the anchor is interpreted as the full length of the hook, the hooks shown in figure 13 extend from a tubular body section which is interpreted as part of the anchor, thus the slits extend to and beyond the ends of the hooks 104/1440 where they join into the tubular body section of the anchor).
With regards to claim 23, Yellin discloses wherein the openings in the hooks 1440 further include multiple holes (the combination of the hooks 104/1440 provide multiple holes), with these holes being connected with a suture; and wherein a single length of suture passes through several of the multiple holes (functional limitation – paragraph 137 – slits shown in 1440 in combination with the plurality of hooks 104 – and thus the holes are capable of being connected with a suture wherein the suture can pass through several of the multiple holes. The suture is not positively recited and thus the holes are capable of meeting the claimed limitation).
With regards to claim 24, Yellin discloses wherein the openings include several separate slits in line along the length of the hooks 104/1440 (figures 1B and 14– the combination of the hooks 104/1440 provide multiple openings which also provides the slits, therefore several separate slits being formed in line along the length of the hooks 104/1440 as disclosed in paragraph 137).
With regards to claim 25, Yellin discloses wherein the anchor 100 is formed from a tube that has been cut to provide tines extending from one end of the tube, with these tines then having been curved and heat set to form the hooks 104 (paragraph 63).
With regards to claim 26, Yellin discloses wherein the anchor 100 includes a locking mechanism (see Note below) arranged to clamp the line when no force is applied to the locking mechanism (paragraph 65 – functional limitation - locking mechanism are the male and female components of the device, when assembled into the deployed state (ring shape), is capable of clamping a line in between the male and female components when no force is applied).
Note – 112(f) interpretation – Applicant’s locking mechanism is a resiliently deformable locking segment that may be formed in a wall of the anchor and divided from the wall by one or more slits and clamps the cord when no force is applied (page 33 lines 15-19); Yellin’s locking mechanism are the male and female components of the device that includes a control window that allows one or more lines or sutures to exit the hypotube 102 and snap lock the internal body member 100 into a ring shape (paragraph 65); therefore both locking mechanisms are equivalent in clamping/securing the line/chord when no force is applied to the locking mechanism.
With regards to claim 28, Yellin discloses wherein the slits extend along all of the length of the hooks 1440 (paragraph 137 – “Anchor design 1440 employs a single ovoid or rounded-rectangular cutout along the length of the anchor” – the length of the anchor is interpreted as the full length of the hook).
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.
Claims 29-30 are rejected under 35 U.S.C. 103 as being unpatentable over Yellin in view of Carson et al. (WO 2009/143227), hereinafter known as “Carson.”
With regards to claims 29-30, Yellin discloses the anchor as claimed in claim 1. Yellin is silent wherein opening defining the slits widen at the end of the slits where the slits meet the tubular body section of the anchor (claim 29); and wherein the slits comprise circular or triangular openings at the ends of the slits (claim 30).
However, in a similar field of endeavor of anchors, Carson teaches (Figure 4J) wherein opening defining the slits 345 widen at the end 346 of the slits 345 (paragraph 94); and
wherein the slits 345 comprise circular openings 346 at the ends of the slits 345 (paragraph 94).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the anchor of Yellin to include wherein opening defining the slits widen at the end of the slits as taught by Carson for the purpose of allowing the alleviation of stress during bending (paragraph 94 of Carson).
The combination of Yellin in view of Carson results in wherein opening defining the slits (Yellin: slits of 1440) widen at the end of the slits (Carson: widened openings 346 at the end of the slits) where the slits (Yellin: slits of 1440) meet the tubular body section of the anchor (Yellin: paragraph 137 – “Anchor design 1440 employs a single ovoid or rounded-rectangular cutout along the length of the anchor” – the length of the anchor is interpreted as the full length of the hook, the hooks shown in figure 13 extend from a tubular body section which is interpreted as part of the anchor, thus the slits extend to and beyond the ends of the hooks 104/1440 where they join into the tubular body section of the anchor; see annotated figure 13 above).
Allowable Subject Matter
Claim 27 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.
The following is a statement of reasons for the indication of allowable subject matter:
With regards to claim 27, the allowable subject matter of “wherein the locking mechanism comprises a locking ring that is able to be elastically deformed to release the line from the locking mechanism for adjustment of the length of the line” overcomes the prior art of Yellin since Yellin’s locking mechanism are male and female component that couple together, additionally the male and female component are not elastically deformable to release a line for adjustment of the line.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MOHAMMED S ADAM whose telephone number is (571)272-8981. The examiner can normally be reached 8-5.
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/MOHAMMED S ADAM/Examiner, Art Unit 3771 06/11/2026
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