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 .
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 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 1, lines 6-7 recite “causing the second fixing edge to keep in a freely stretching state, and suturing the second fixing edge onto the valve skirt”. “causing the second fixing edge to keep in a freely stretching state” appears to be a literal translation into English from a foreign document and has grammatical and idiomatic errors. Further, it is unclear what is meant by “a freely stretching state”. How can the edge be in a freely stretching state when it is sutured to the valve skirt? As best understood, “causing the second fixing edge to keep in a freely stretching state” is interpreted to mean that the second fixing edge remains unfolded when it is sutured to the valve skirt.
Claim 7 is unclear for the same reasons as claim 1 since lines 8-9 recite “causing the second fixing edge to keep in a freely stretching state”.
Claim 7 recites the limitation "a second fixing edge" in line 12. It is unclear if this is the same second fixing edge as the second fixing edge recited in line 4.
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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1 and 7 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Qi et al. US 2022/0287832 (hereafter referred to as Qi).
Regarding claim 1, Qi discloses a method for suturing a valve leaflet 1, comprising: demarcating first fixing edges 21, 41, 51 on both sides of a leaflet 1 (fig.3) and a second fixing edge 11 at bottom of the leaflet (par.138-140 discloses marks for the folding lines which is considered demarcating the first and second fixing edges at least because the folding lines distinguish between 11 and 21), folding the first fixing edges towards a region between a valve skirt 6 and the leaflet, and suturing C the first fixing edges onto the valve skirt (figs. 8-9); and causing the second fixing edge to keep in a freely stretching state (interpreted to mean keeping the second fixing edge unfolded), and suturing the second fixing edge onto the valve skirt 6 (par.145; fig.9).
Regarding claim 7, the rejection of claim 1 above explains the process by which the valve of Qi is manufactured, including the first and second fixing edges of the leaflet being fixedly sutured on the valve skirt. Qi further discloses a valve frame 7, wherein the valve skirt 6 covers an inner wall surface of the valve frame (fig.9; par.145).
Claim Rejections - 35 USC § 103
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 2, 3, 5, and 6 are rejected under 35 U.S.C. 103 as being unpatentable over Qi as applied to claim 1 above, and further in view of Miller US 2014/0277418 (hereafter referred to as Miller).
Regarding claims 2 and 3, Qi discloses the method of claim 1 as discussed above. Qi has a transition region located near L1 in fig.3, but does not disclose providing a transition hole position at a transition region that is formed between the first fixing edges and the second fixing edge or cutting an incision at an edge of the transition region.
Miller teaches a method of suturing a valve leaflet, in the same field of endeavor, wherein sewing holes 92 are provided in the leaflet (fig.4) for the purpose of facilitating subsequent assembly operations (par.27). Miller further teaches the leaflets are joint to a skirt via the sewing holes 92 (par.41). Miller also discloses folding slots 126 for easier folding (par.38).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to add the sewing holes taught by Miller along at least the bottom edge of the leaflet of Qi in order to facilitate sewing the leaflet to the skirt. As modified, a hole positioned adjacent to seam L1 is considered a transition hole position. It would have been further obvious to provide a folding slot/incision as taught by Miller near the seam L1 of Qi in order to allow for easier folding of the material.
Regarding claims 5 and 6, Qi in view of Miller discloses the method substantially as claimed and as discussed above. While Qi does not specifically disclose a particular sequence of passing the suture through the first and second fixing edges, the skirt, and the transition hole, there are a finite number of identified, predictable sequences with a reasonable expectation of success and it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to try one of the finite number of sequences to arrive at the claimed invention (see MPEP 2143E).
Allowable Subject Matter
Claim 4 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include 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: Qi discloses the method of claim 1 and Miller generally teaches holes and incisions, but Qi and Miller do not disclose a transition hole and incision wherein a distance between one end of the incision away from the edge of the transition region and the transition hole position is 1/3 to 2/3 of a distance between the transition hole position and the edge of the transition region, and the incision extends in a direction from the edge of the transition region to the transition hole position.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Braido et al. US 2015/0173899 discloses a leaflet that is secured to a cuff by suturing, wherein only upper regions of the leaflet are folded for the purpose of decreasing bulk (par.86).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MEGAN Y WOLF whose telephone number is (571)270-3071. The examiner can normally be reached Mon-Fri 8am-2pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melanie Tyson can be reached at (571)272-9062. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MEGAN Y WOLF/Primary Examiner, Art Unit 3774
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