DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of pre-AIA 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 –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
Claim(s) 1-6,16-19 are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Banbury et al. (2006/0287716). Banbury et al. disclose a chordal replacement method comprising: passing a first needle, which is coupled to a first suture length 30, through papillary muscle, paragraph 18. Fig. 4 shows securing a pledget 32 which is coupled to the first suture length, to the papillary muscle 64 in response to passing the first needle through the papillary muscle. Banbury et al. disclose (paragraph 15) passing a second needle (paragraph 18), which is coupled to a second suture length 14, through valve tissue, (paragraph 30) securing the second suture length, which is coupled to the pledget 32, to the valve tissue in response to passing the second needle through the valve tissue. Fig. 4 shows passing a third needle (paragraph 18 since suture strands have a needle used to pass through leaflet), which is coupled to a third suture length, through the valve tissue; securing the third suture length, which is coupled to the pledget 32, to the valve tissue in response to passing the third needle through the valve tissue; wherein the second and third suture lengths are not monolithic with each other and do not constitute a single suture as seen in Fig. 4 these are separate loops. With respect to claim 2, Fig. 4 shows the second suture length couples to a fourth needle and the third suture length couples to a fifth needle (ends have needles, see paragraph 4), the method further comprising: passing the fourth needle through the valve tissue; further securing the second suture length to the valve tissue 61 in response to passing the fourth needle through the valve tissue 61; passing the fifth needle through the valve tissue; further securing the third suture length to the valve tissue 61 in response to passing the fifth needle through the valve tissue 61. Note the different loops establishing different sutures. With respect to claim 3, it can be understood as seen in Fig. 4 the first suture 30 length couples to a sixth needle since two ends of suture pass through the papillary muscle 64, thus the method inherently involves passing the sixth needle through the papillary muscle. Regarding claim 4, Fig. 4 shows a first suture loop 30 with the first suture length, the first suture loop (as there are two strand ends shown thus it inherently is ) traversing the pledget 32. Regarding claim 5, Banbury discloses (paragraph 28) the first suture loop traverses the papillary muscle. With respect to claim 6, Fig. 1 shows the first and sixth needles 34 are on opposing ends (paragraph 28) of the first suture length 30; the second and fourth needles are on opposing ends of the second suture length (paragraph 4); the third and fifth needles are on opposing ends of the third suture length, Fig. 4 shows the individual loops 14 are each secured separately, thus each has first and second needles coupled to each loop. Regarding claim 16, the second suture 14 length couples to a fourth needle at one end of the second suture length and couples to the second needle at another end of the second suture length (paragraph 4), the method further comprising: securing the second suture length to the valve tissue by passing the fourth needle through the valve tissue (see Fig. 4 showing different exit sites for needles) and then coupling the one end of the second suture length to the another end of the second suture length via at least one of a knot, a coupling member, or combinations thereof (see paragraphs 5,16). Regarding claim 17, Fig. 4 shows forming a second suture loop 14 with the second suture length, the second suture loop traversing the valve tissue. See the multiple site entries for needles. Regarding claim 18, the third suture length (see Fig. 4 showing multiple suture loops) couples to a fifth needle (paragraph 4) at one end of the third suture length and couples to the third needle at another end of the third suture length, the method further comprising: securing the third suture length to the valve tissue 61 by passing the fifth needle through the valve tissue (see Fig. 4 showing different exit sites for needles) and then coupling the one end of the third suture length to the another end of the third suture length via at least one of a knot, a coupling member, or combinations thereof (see paragraphs 5,16). Regarding claim 19, Fig. 4 shows forming a third suture loop 14 with the third suture length, the third suture loop traversing the valve tissue. See the multiple site entries for needles.
Allowable Subject Matter
Claims 7-15 are 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.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Scorsin et al. (2009/0177274) teach a chordae prosthesis having a pledget along with sutures and needles attached to ends of suture strands.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIAN E PELLEGRINO whose telephone number is (571)272-4756. The examiner can normally be reached 8:30am-5:00pm M-F.
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/BRIAN E PELLEGRINO/Primary Examiner, Art Unit 3799
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