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 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.
In claim 1, “tension member for coupling” has been interpreted under its broadest reasonable interpretation as it appears the applicant did not intend to invoke 112f since no structural interpretation of the phrase has been provided in the disclosure.
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) 1-2, 4-6, 9-11, 16-18 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Tylis (2017/0135817A1).
In regard to claim 1, Tylis discloses a method for approximating papillary muscles of a heart, the method comprising:
deploying a first heart anchor 140 to an external posterior surface of the heart proximate a papillary muscle of the heart; (fig 1B)
deploying a second heart anchor 136 to an external anterior surface of the heart proximate a papillary muscle of the heart; (fig 1B)
tensioning a tension member 104 for coupling the first heart anchor 140 to the second heart anchor 136 (see fig 1B)
and locking the tension member 104 in tension between the first heart anchor 140 and the second heart anchor 136 across a ventricle of the heart. (see fig 1B; ventricle 116; [0180: tension member may be secured; cord locker may be used to lock the tension member])
In regard to claim 2, Tylis discloses the claim limitations as discussed in the rejection of claim 1, and further discloses the second heart anchor 136 is deployed to the external anterior surface of a left ventricle. (see fig 1B)
In regard to claim 4, Tylis discloses the claim limitations as discussed in the rejection of claim 1 and further discloses the first heart anchor or the second heart anchor (136, 140) includes:
a ring 152 having two ends (172) and configured to move from a linearized configuration to a ring-shaped configuration; (see fig 3B-3A)
and a cover 156 coupled to the ring and extending inward from the ring in the ring-shaped configuration. (fig 3A-B)
In regard to claim 5, Tylis discloses the claim limitations as discussed in the rejection of claim 4, and further discloses the ring 152 is configured to be in the linearized configuration in an unexpanded configuration and configured to be in the ring-shaped configuration in an expanded configuration. (fig 3A-B; [0108])
In regard to claim 6, Tylis discloses the claim limitations as discussed in the rejection of claim 1, and further discloses both the first heart anchor 140 and the second heart anchor 136 include:
a ring 152 having two ends 172 and configured to move from a linearized configuration to a ring-shaped configuration (fig 3A-B; [0099]);
and a cover 156 coupled to the ring 152 of a respective one of the first heart anchor or the second heart anchor and extending inward from the ring of the respective one of the first heart anchor or the second heart anchor in the ring-shaped configuration. (fig 3A-B; [0098: self expandable anchor 148 may be utilized for both of the superior and inferior anchors 136, 140]
In regard to claim 9, Tylis discloses the claim limitations as discussed in the rejection of claim 1, and further discloses moving the first heart anchor 140 from an unexpanded configuration to an expanded configuration at the external posterior surface of the heart. [0014: pulling the tension member produces the expanded configuration; pulls the anchor against the exterior surface of the heart wall; 0099-0100; fig 1B]
In regard to claim 10, Tylis discloses the claim limitations as discussed in the rejection of claim 1, and further discloses deploying the first heart anchor 140 to the external posterior surface of the heart (see fig 1B), the first heart anchor 140 configured to have a static size. The anchor will have a static size once deployed since the ring attaches together as shown in figure 3A, in as much as that of the instant invention which also goes from a linear to a ring shaped state.
In regard to claim 11, Tylis discloses the claim limitations as discussed in the rejection of claim 1, and further discloses passing a deployment apparatus (interpreted as a catheter 700) through the external posterior surface of the heart [0163: puncture wall of the left ventricle; 0164: exterior posterior surface of left ventricle],
the deployment apparatus including an implant retention area (interpreted as the lumen 704 which retains the implant by keeping it within until delivered [0156] for retaining the first heart anchor in an unexpanded configuration [0156];
and deploying the first heart anchor 140 to the external posterior surface of the heart from the implant retention area (fig 1B, 2B).
In regard to claim 16, Tylis meets the claim limitations as discussed in the rejection of claim 1, and further discloses drawing the first heart anchor 140 to the external posterior surface of the heart (fig 2B);
and coupling a proximal portion of the tension member 104 to the second heart anchor 136. [0180: tension member secured relative to the first anchor and second anchor]
In regard to claim 17, Tylis discloses the claim limitations as discussed in the rejection of claim 1, and further discloses extending the tension member 104 from the first heart anchor 140 across an interior cavity of the ventricle 116 to the external anterior surface (at 136) (see fig 1B, 2B);
and coupling a proximal portion of the tension member 104 to the second heart anchor 136. (see fig 2B; [0180: tension member secured relative to the first and second anchors])
In regard to claim 18, Tylis discloses the claim limitations as discussed in the rejection of claim 1, and further discloses tensioning the tension member 104 (see fig 1B; [0180: tension member may be secured; cord locker may be used to lock the tension member]) during a beating heart procedure. [0012: procedure preferably done on a beating heart]
Claim(s) 3, 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tylis (2017/0135817A1) in view of McCarthy (2006/0161040A1).
In regard to claim 3, Tylis meets the claim limitation the claim limitations as discussed in the rejection of claim 1, and further teaches the first heart anchor 140 is deployed (fig 1B) and that the exact placement may vary [0093].
However, Tylis does not teach the deployment is to the external posterior surface of the left ventricle (although the placement is very close in figure 1B).
McCarthy teaches installing a splint from the anterior to the posterior surface of the left ventricle. (figure 43D)
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to deploy the anchor of Tylis to the external posterior surface of the left ventricle as taught by McCarthy because this placement reduces wall stress and improves pumping efficient (abstract) and facilitates the contractile ability of the entire ventricle (Col 24, lines 17-30).
In regard to claim 7, Tylis meets the claim limitations as discussed in the rejection of claim 1, and further teaches a lock for locking the tension member 104 to the second heart anchor 136 [0180: cord locker maybe used to lock the tension member relative to an anchor].
However, Tylis does not teach the first and second heart anchors (140, 136) each include a pad.
McCarthy teaches the first heart anchor includes a pad and the second heart anchor includes a pad [0032-0033].
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to use the pads of McCarthy with the anchors of Tylis because the pads prevent trauma to the tissue [0032: atraumatic pads].
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tylis (2017/0135817A1) in view of Schroeder (2005/0075723A1).
In regard to claim 8, Tylis meets the claim limitations as discussed in the rejection of claim 1, but does not teach the second heart anchor includes a ratchet mechanism.
Schroeder teaches the second heart anchor includes a ratchet mechanism configured to allow the tension member to be drawn through the second heart anchor in a first direction and resist movement of the tension member in a second direction that is opposite the first direction. [0153: a one way ratchet surface may be disposed on the inner surface of the anchor to prevent its displacement]
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to use the ratchet surface of Schroeder on the second heart anchor of Tylis because this prevents displacement of the anchor relative to the tension member in one direction [0153], which is helpful in tightening the tensioning member.
Claim(s) 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tylis (20170135817A1) in view of Annest (EP2150312B1).
In regard to claim 19, Tylis meets the claim limitations as discussed in the rejection of claim 18 but does not teach rapid pacing the heart.
Annest teaches rapid pacing the heart. [0066: some further alternatives can be employed to selectively approximate the tissues while the pressures in the heart are temporarily reduced including rapid pacing of the heart]
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to rapid pace the heart during the surgical procedure of Tylis because the rapid pacing allows the surgeon to check the tension of the splint during the surgery. [0066: some further alternatives can be employed to selectively approximate the tissues while the pressures in the heart are temporarily reduced including rapid pacing of the heart]
Claim(s) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tylis (20170135817A1) in view of Reimer (2020/0085576A1).
In regard to claim 20, Tylis meets the claim limitations as discussed in the rejection of claim 1, and further teaches wherein the first heart anchor 140 is deployed to the external posterior surface of the heart proximate (near) the posterior medial papillary muscle, (fig 2B)
and wherein the second heart anchor 136 is deployed to the external anterior surface of the heart proximate (near) the anterior lateral papillary muscle and extending the tension member 104 across the ventricle (fib 2B) by puncturing the heart walls [0167; fig 2B].
While Tylis teaches the placement of the splint and components may vary [0093], Tylis does not teach puncturing a posterior medial papillary muscle or the ventricle or an anterior lateral papillary muscle of the ventricle.
Reimer teaches puncturing a posterior medial papillary muscle of the ventricle;
puncturing an anterior lateral papillary muscle of the ventricle;
and extending the tension member across the ventricle through the posterior medial papillary muscle and through the anterior lateral papillary muscle (papillary muscles 28a,b; with tension member 140 in figures 5-6).
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to position the tensioning member of Tylis through the papillary muscles as taught by Reimer because this positioning stabilizes prosthetic atrioventricular valves [0009] and reduces ventricular dilation [0012].
Claim(s) 12-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tylis (2017/0135817A1) in view of Hariton (WO2013128461A1).
In regard to claim 12, Tylis meets the claim limitations as discussed in the rejection of claim 11, and further teaches
passing an elongate shaft of the deployment apparatus from an atrium into the ventricle [0172: passing the catheter through the right atrium and into the right ventricle; 0174: puncture the septum; see fig 1B; after puncturing the septum is inserted into the left ventricle]
position a puncturing tip of the elongate shaft to pass through the external posterior surface to deploy the first heart anchor 140 at the external posterior surface [0176 creating an incision by positioning an introducer in the left posterior wall; 0177: deploy an anchor]
and to position the puncturing tip to pass through the external anterior surface to deploy the second heart anchor 136 at the external anterior surface. [0172; anterior surface; 0171: anterior wall; 0099: catheter may be pushed through the wall during delivery].
However, Tylis does not teach the catheter has a steerable distal end.
Harriton teaches steering a steerable distal end of the elongate shaft. (pg 9, lines 10-15: distal end is steerable]
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to make the distal tip of the catheter of Tylis steerable as taught by Harriton because this will provide increased precision during the surgery.
In regard to claim 13, Tylis meets the claim limitations as discussed in the rejection of claim 12,
puncturing the external anterior surface of the heart with the puncturing tip of the deployment apparatus; [0176: puncturing from inside the left ventricle to outside the left ventricle]
However, Tylis teaches extending the deployment apparatus (Catheter 700) across an interior cavity of the ventricle from the external posterior to external anterior surface instead of anterior to posterior (as shown in figures 1-2B)
It has been held that a mere reversal of steps of the working parts of an invention, yielding a predictable result, requires no more than routine skill in the art. Accordingly, it would have been obvious to one of ordinary skill in the art at the time the invention was filed to extend the needle from the anterior to the posterior surface instead of posterior to anterior for easier access. Absent a teaching of criticality (new or unexpected results), this arrangement is deemed to have been known by those skilled in the art at the time the invention was filed. MPEP 2144.04VIA
Claim(s) 14-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tylis (20170135817A1).
In regard to claim 14, Tylis meets the claim limitations as discussed in the rejection of claim 1, and further teaches puncturing the external anterior surface [0176: puncturing from inside the left ventricle to outside the left ventricle] with a needle the needle having an interior lumen (504: needle catheter; [0140]; fig 20B; [0012: curved needle comprising a hollow tube]);
puncturing the external posterior surface [0176: posterior wall; 0017] with the needle;
extending the needle across an interior cavity of the ventricle from the external posterior surface (as shown in figure 1B the picture across the septum also crosses the anterior surface) to the external anterior surface;
and deploying a snare from the interior lumen of the needle external of the external posterior surface. [0164; 1079]
However, Tylis teaches extending the deployment apparatus (Catheter 700) across an interior cavity of the ventricle from the external posterior to external anterior surface instead of anterior to posterior (as shown in figures 1-2B)
It has been held that a mere reversal of steps of the working parts of an invention, yielding a predictable result, requires no more than routine skill in the art. Accordingly, it would have been obvious to one of ordinary skill in the art at the time the invention was filed to extend the needle from the anterior to the posterior surface instead of posterior to anterior for easier access. Absent a teaching of criticality (new or unexpected results), this arrangement is deemed to have been known by those skilled in the art at the time the invention was filed. MPEP 2144.04VIA
In regard to claim 15, Tylis meets the claim limitations as discussed in the rejection of claim 14 and further teaches utilizing the snare to extend the tension member across the interior cavity of the ventricle. [0164; 0179]
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTIE BAHENA whose telephone number is (571)270-3206. The examiner can normally be reached M-F 9-3.
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/CHRISTIE BAHENA/Primary Examiner, Art Unit 3774
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