DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 01/22/26 has been entered.
Response to Arguments
Applicant's arguments filed 01/22/26 have been fully considered but they are not persuasive.
On pages 6-8 regarding prior art rejections Applicant argues amendments overcome the rejections of record.
The Examiner respectfully refers to the rejection below regarding amended claims.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1, 7-9, 12, 15, 17, 19-21 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claims 1 and 20 are rejected for having new matter, for claiming the sutures pass through the aortic wall above the native aortic cusps. The originally filed disclosure, both in the specification and figures, fails to have support for the sutures passing above native aortic cusps. Instead, both the figures and disclosure appear to show the exact opposite, with the sutures passing “under” the native cusps 22. This is accordingly considered to be new matter.
There is further new matter for claiming the pledgets are located “within the valve” as there is likewise no support for this in the originally filed disclosure. There is no indication the pledgets are within the valve as the claim is requiring.
Remaining claims are rejected for depending on a claim with new matter.
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 1, 7-9, 12, 15, 17, 19-21 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.
Claims 1 and 20 are indefinite for claiming the sutures pass through the aortic wall above the native aortic cusps, but this is unclear. Notably, the disclosure fails to discuss the sutures passing above native aortic cusps, and the disclosure appears to disclose the exact opposite, with the sutures extending under native cusps 22. Likewise, the claims indicate that the device is sutured under the native annulus, making it unclear how the sutures are passing above the cusps of the native valve at the same time.
The claims are further indefinite for claiming the pledgets are positioned “within the valve”, when the figures and disclosure appear to have the pledgets positioned above a valve as opposed to within it. It is unclear how the pledgets can be positioned within the valve and the suturing method have the suturing also occur above native cusps. The disclosure does not elaborate on this making it unclear how all the requirements of the claim can happen at the same time.
Remaining claims are rejected 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, 7, 12, 15, 17 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Carpentier et al. (US 6231602 B1) hereinafter known as Carpentier in view of Garrison et al. (US 5972030 A) hereinafter known as Garrison, and further in view of Berg et al. (US 20030171805 A1) hereinafter known as Berg, further in view of Cohn et al. (US 6610071 B1), hereinafter known as Cohn.
Regarding claim 1, as is best understood (see the 112 rejections above), Carpentier discloses a method of repairing an aortic valve (Abstract), having an aortic wall (Figure 1a item 20), native aortic cusps (Figure 1a item 18), and commissures (Figure 1a item 30), comprising:
selecting an intra-annular mounting frame (Figure 3) which has a height (Figure 3) and diameter (Figure 3) and comprises curvatures (Figure 4 item 40) with ends and points interconnecting the ends (Figure 4 item 38), inserting the frame into an aortic valve annulus below the native aortic cusps (Figure 1a item 32a) with the curvatures positioned adjacent to where the native cusps connect to the aortic wall (Figure 1a), and suturing the frame to the aortic annulus with sutures passing through the frame (Column 4 lines 27-33), further passing into the aortic wall beneath the aortic valve annulus (Column 6 lines 26-31), to implant the frame inside the aortic valve below the native cusps (Column 6 lines 26-28; Column 8 lines 11-14) so as to reorient the native aortic cusps within the aortic valve (Column 8 lines 14-15 if the annulus is restored to its normal circumference, it is considered inherent that the cusps attached thereto would be “reoriented” as the shape of the annulus to which they attach has changed),
but is silent with regards to measuring a dimension of the aortic valve to determine a size for the frame, and selecting the frame based on the measured dimension,
a post extending from each point,
and the method of suturing including passing the sutures through the curvatures of the frame, and through pledgets positioned within the aortic valve above the native aortic cusps.
However, regarding claim 1 Garrison teaches measuring at least one dimension of the aortic valve (Column 28 line 5) to determine a size for an intra-annular mounting frame and selecting a frame based on the measured dimension (Column 27 lines 54-56). Carpentier and Garrison are involved in the same field of endeavor, namely annuloplasty rings. It would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the method of Carpentier to determine the size of the native valve before implanting the frame as is taught by Garrison in order to ensure the frame being implanted will be suitable for the patient requiring valve correction. This will ensure safety and efficacy after the procedure and long-lasting results.
Further, regarding claim 1 Berg teaches a heart valve frame which includes a post (Figure 13 item 43) extending from each point (Figure 13 item 45) connecting each curvature (see Figure 12). Carpentier and Berg are involved in the same field of endeavor, namely annuloplasty rings. It would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the method of the Carpentier Garrison Combination to modify the frame so there are posts extending from the points as is taught by Berg in order to provide additional stability within the heart valve structure.
Further, regarding claim 1 Cohn teaches a method of suturing a prosthetic valve to an annulus which includes sutures passing through the valve (Figure 6 item 20), further passing into the annulus (Figure 6 item 24), and further passing through pledgets positioned on the opposite side of the annulus from the prosthetic valve (Figure 6 (the Examiner notes that while the numbering within this figure shows item 16 pointing at suture 12, the pledget number throughout is understood to be item 16, the oval/oblong element under the annulus 24). Carpentier and Cohn 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 method of the Combination so that the method of suturing includes pledgets as is taught by Cohn in order to prevent the sutures from tearing through native tissue, reducing leaks around the suture site, and/or to help securely attach the valve to the annulus. The Examiner notes further, that within the Combination, which shows how pledgets/sutures are used to secure the annulus of the valve in its entirety, the sutures would extend additionally through the curvatures of the frame in addition to posts (shown by Carpentier) in order to ensure the entirety of the annulus is secured as is desired.
Regarding claim 7, the Carpentier Garrison Berg Cohn Combination teaches the method of claim 1 substantially as is claimed,
wherein Garrison further teaches measuring the dimension comprises measuring a length of the native cusps (Column 28 line 6; the “width” is considered a length of the native anterior leaflet cusp).
Regarding claim 15, the Carpentier Garrison Berg Cohn Combination teaches the method of claim 7 substantially as is claimed,
but is silent with regards to measuring the length of at least two of the cusps.
However, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the method of the Carpentier Garrison Berg Cohn Combination to measure the dimension at least two of the cusps in order to determine the size of the frame to reshape the valve, since the replaced valve of Duran is an aortic valve, which includes more than two cusps. In other words, when measuring the dimensions of the anterior leaflet of the mitral valve of Garrison, there are only two leaflets to measure, meaning the space not occupied by the anterior leaflet will be occupied by the posterior leaflet, and only one leaflet needs to be measured. However, an aortic valve has an anterior, posterior, and left coronary leaflet, and so at least two of the leaflets should be measured in order to understand the dimensions of all three.
Regarding claim 12, the Carpentier Garrison Berg Cohn Combination teaches the method of claim 1 substantially as is claimed,
wherein Carpentier further discloses the frame’s diameter is about 16 mm to about 30 mm (Column 3 lines 46-47).
Regarding claim 17, the Carpentier Garrison Berg Cohn Combination teaches the method of claim 1 substantially as is claimed,
wherein Carpentier further discloses reorienting the native cusps and commissures of the valve (Column 8 lines 4-15 the frame reorients the annulus (and so attached cusps and commissures) to the “normal” circumference) so the aortic valve has a diameter from 16-30 mm (Column 3 lines 46-47 the “normal” annulus diameter is 17-29 mm).
Claim(s) 8 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Carpentier, Garrison, Berg, and Cohn as is applied above, further in view of Northrup et al. (US 5961539 A) hereinafter known as Northrup.
Regarding claim 8, the Carpentier Garrison Berg Cohn Combination teaches the method of claim 7 substantially as is claimed,
but is silent with regards to measuring the length of the native cusps includes measuring a free edge of one of the cusps from one commissure of the native valve to the next.
However, regarding claim 8 Northrup teaches a method of measuring the length of the native cusps which includes measuring a free edge of one of the cusps from one commissure of the aortic valve to a next commissure of the aortic valve (Figure 13; Column 1 lines 23-25; Column 15 lines 34-45). Carpentier and Northrup are involved in the same field of endeavor, namely dysfunctional valves. It would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the method of the Carpentier Garrison Berg Cohn Combination to measure any dimension of the native valve, including a length from a free edge between commissures, as is taught by Northrup, in order to determine the size of the frame to reshape the valve 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, the person of ordinary skill would have found it obvious to try to measure any dimension of the native valve in order to determine its reshaped size and frame to achieve that size.
Claim(s) 9, 19-21 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Carpentier in view of Garrison, Berg, and Cohn as is applied above, further in view of Duran (US 5258021 A).
Regarding claim 9, the Carpentier Garrison Berg Cohn Combination teaches the method of claim 1 substantially as is claimed,
wherein Garrison further teaches measuring the dimension of the aortic valve (Column 28 line 5) to determine a final size of a repaired valve (Column 27 lines 54-56),
but is silent with regards to determining a calculated radius and a calculated diameter of a repaired valve from the measuring the dimension of the aortic valve.
However, regarding claim 9 Duran teaches determining a calculated diameter of a repaired valve and selecting a frame to approximate this diameter (Figure 4 item “DIA”), and also teaches the size and diameter of the frame are related (Column 4 lines 5-7). Further, while Duran fails to disclose determining a calculated radius and selecting the frame based thereupon, the determination of the diameter is understood to be similar enough to provide the same information since a radius is half the diameter.
Carpentier and Duran are involved in the same field of endeavor, namely valve repair. It would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the method of the Combination to calculate the diameter and/or radius of the repaired valve and select the frame therefrom since 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, using any dimension of the repaired valve would have been obvious to one of ordinary skill to use. Additionally, the use of the diameter and radius are considered equivalents in the art. In this case, a radius and diameter are understood to both be predictable for a final valve.
Regarding claim 19, the Carpentier Garrison Berg Cohn Combination teaches the method of claim 1 substantially as is claimed,
but is silent with regards to the posts extending from the points at an angle of 1-30 degrees.
However, regarding claim 19 Duran teaches the frame extends from points at an angle of 1-30 degrees when measured from a vertical plane of the frame (Figure 2, Column 6 lines 27-30 the valve frame extends at about a 10 degree angle).(See also the modification in view of Berg, who teaches the frame can be structured to include posts (Fig 13 item 43)). Carpentier and Duran are involved in the same field of endeavor, namely valve repair. It would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the method of the Combination to have the posts extend at an angle as is taught by Duran so the physician can optimize or adjust the valve connection to native heart structure, thus creating as tight or loose of a seal as may be desired.
Regarding claim 20, the Carpentier Garrison Berg Cohn Combination teaches the method of claim 1 substantially as is claimed,
wherein Garrison further teaches measuring the dimension of the aortic valve (Column 28 line 5) to determine a final size of a repaired valve (Column 27 lines 54-56),
but is silent with regards to determining a calculated radius and a calculated diameter of a repaired valve from the measuring the dimension of the aortic valve.
However, regarding claim 20 Duran teaches determining a calculated diameter of a repaired valve and selecting a frame to approximate this diameter (Figure 4 item “DIA”), and also teaches the size and diameter of the frame are related (Column 4 lines 5-7). Further, while Duran fails to disclose determining a calculated radius and selecting the frame based thereupon, the determination of the diameter is understood to be similar enough to provide the same information since a radius is half the diameter.
Carpentier and Duran are involved in the same field of endeavor, namely valve repair. It would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the method of the Combination to calculate the diameter and/or radius of the repaired valve and select the frame therefrom since 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, using any dimension of the repaired valve would have been obvious to one of ordinary skill to use. Additionally, the use of the diameter and radius are considered equivalents in the art. In this case, a radius and diameter are understood to both be predictable for a final valve.
Regarding claim 21, the Carpentier Garrison Berg Cohn Duran Combination teaches the method of claim 20 substantially as is claimed,
wherein Carpentier further discloses reorienting the native cusps and commissures of the valve (Column 8 lines 4-15 the frame reorients the annulus (and so attached cusps and commissures) to the “normal” circumference) so the aortic valve has a diameter from 16-30 mm (Column 3 lines 46-47 the “normal” annulus diameter is 17-29 mm).
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 04/14/26
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