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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 03/03/26 has been entered.
Response to Arguments
Applicant's arguments filed 01/30/26 have been fully considered but they are not persuasive.
On page 6 regarding drawing objections, Applicant argues amendments overcome the objections of record.
The Examiner respectfully agrees and withdraws drawing objections of record.
On pages 6-7 regarding prior art rejections, Applicant argues amendments overcome the rejection of record.
The Examiner respectfully refers to the rejection below regarding amended claims.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 3 and 22-23 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 3 is indefinite for claiming “each of the plurality of arms extend from an apex of the first row of…cells to the connection points”, when claim 1, from which this claim depends, has already claimed that “a plurality of arms” extend between the inner and outer frame so each of the arms is “a connection point between the inner frame and outer frame”. It is unclear how the arms can extend to the connection points when claim 1 has already defined the arms being the connection point. It appears the limitations of claim 1 and 3 cannot be met at the same time.
Claim 22 is unclear for further claiming the first row of outer frame cells comprises a first plurality of diamond-shaped cells, but this is unclear. Notably, the disclosure/figures appear to indicate that there is a row of cells, and those cells are diamond-shaped. This is in contrast to the claim however, which claims that the cells of the first row also have diamond-shaped cells. However, as the Examiner best understands, the outer cells do not further comprise cells, as the claim requires. The claim is rendered further unclear for referring to “adjacent cells of the first plurality of cels of the diamond-shaped cells”, since the diamond-shaped cells do not have “first plurality of cells”.
Remaining claims are indefinite for depending on an indefinite claim.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1, 24-25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Noe et al. (US 20230277307 A1) hereinafter known as Noe in view of Rahmig et al. (US 20210000593 A1) hereinafter known as Rahmig.
Regarding claim 1 Noe discloses a replacement cardiac valve ([0002]) comprising:
an outer frame (Figure 1c item 106) configured to expand from a collapsed configuration to an expanded configuration ([0008]), wherein a circumference of the outer frame includes a first row of outer frame cells having a first number of cells (Figure 1f, the uppermost row of cells);
an inner frame (Figure 1c item 104) configured to expand from a collapsed configuration to an expanded configuration ([0008]),wherein a circumference of the inner frame includes a first row of inner frame cells having a second number of cells (Figure 1e, the uppermost row of cells); and
a plurality of arms extending between the inner and outer frames, each of the arms being a connection point between the inner frame and the outer frame (Figure 1c item 108; Figure 1d shows twelve connecting arms extending from the outer frame to the inner frame, looking like spokes), the first number of cells (in the outer first row) being a factor of the second number of cells (of the inner first row) such that the connection points between the inner frame and outer frame are symmetric (Figure 1d; twelve is a factor of itself), wherein the arms are configured to isolate the inner frame such that a force exerted on the outer frame is capable of being absorbed by the outer frame and the arms ([0006] “the double wall stent structure decouples ore reduces the effect on the geometry of the retention structure on the geometry of the valve support. This includes external forces acting through the valve annulus during the cardiac cycle”.),
but is silent with regards to the number of the connection points being less than the second number of cells.
However, regarding claim 1, Rahmig teaches a heart valve that includes connections between an inner (2) and outer (1) frame, there being less arm connections (12) than the number of cells in one row of the outer frame (see at least Figures 9-11 and 1a; the number of cells within the inner and outer frames far outnumbers the number of arm connecting points). Noe and Rahmig are involved in the same field of endeavor, namely heart valves. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the number of the connections (or second cells) so there are more (or less) than what is taught by Noe in order to allow the adjustment of flexibility of the connection between the inner and outer frame, thus allowing an adjustment of how much the two frames move relative to the beating of the heart, which allows the valve in question to be optimized according to patient need.
Regarding claim 24 the Noe Rahmig Combination teaches the valve of claim 1 substantially as is claimed,
wherein Noe further discloses at least a portion of each of the arms is curved (see Figure 1a where the arms curve downward to meet the outer frame 106).
Regarding claim 25 the Noe Rahmig Combination teaches the valve of claim 1 substantially as is claimed,
wherein Noe further discloses the inner frame and outer frame are coupled to each other both before and during implantation ([0006] a unibody design is understood to stay coupled for implantation).
Claims 3 and 22-23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Noe and Rahmig as is applied above further in view of McLean et al. (US 20130304200 A1) hereinafter known as McLean.
Regarding claim 3 the Noe Rahmig Combination teaches the valve of claim 1 substantially as is claimed,
wherein Noe further discloses each of the arms extends from the first row of cells of the inner frame the connection points (Figure 1c),
and wherein Rahmig further teaches inner stent heart valve cells can be diamond-shaped (Figure 1a). It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the shape of the cells of the inner frame so they are diamond-shaped as is taught by Rahmig since the courts have held that the simple substitution of one known element for another to obtain predictable results in a prima facie case of obviousness. See MPEP 2143 (I)(B). In this case, the use of any known stent strut/cell shape is considered obvious to substitute.
Further, regarding claim 3, while the Combination is silent with regard to the arms coming from an apex of the second cells, McLean teaches a heart valve with inner and outer frames where connecting arms can originate from an apex of an inner frame cell (Figures 45a-b items 360, 370). Noe and McLean are involved in the same field of endeavor, namely prosthetic heart valves. It would have been obvious to have the arms originate from the apex of the cells of the Noe Rahmig Combination as is taught by McLean since the courts have held that choosing from a finite number of identified, predictable solutions with a reasonable expectation of success results in a prima facie case of obviousness. See MPEP 2143 (I)(E). In this case, it would be obvious to have arms originate from any known area of the cells to connect the inner and outer frame.
Regarding claim 22 the Noe Rahmig McLean Combination teaches the valve of claim 3 substantially as is claimed,
wherein Noe further discloses the connection points to the outer frame are between adjacent cells of the first plurality of cells of the outer frame (Figure 1a),
and wherein Rahmig further teaches the outer frame first number of cells can be diamond-shaped (Figure 1a). It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the shape of the cells of the outer frame so they are diamond-shaped as is taught by Rahmig since the courts have held that the simple substitution of one known element for another to obtain predictable results in a prima facie case of obviousness. See MPEP 2143 (I)(B). In this case, the use of any known stent strut/cell shape is considered obvious to substitute.
Regarding claim 23 the Noe Rahmig McLean Combination teaches the valve of claim 3 substantially as is claimed,
wherein Rahmig further teaches connection points can be located at a central portion of the outer frame (Figure 9 shows arms 12 which connect the inner frame from an apex thereof to a central portion of the outer frame). It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the location the arms connect to the outer frame so they connect to a central portion thereof, since it is a known alternative to connecting at an end of the outer frame (e.g. see Rahmig figure 9, 11).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jacqueline Woznicki whose telephone number is (571)270-5603. The examiner can normally be reached M-Th 10am-6pm EST.
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/Jacqueline Woznicki/Primary Examiner, Art Unit 3774 04/15/26
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